MARIANDINA NUTRITIONAL HEALTH PRODUCTS

“Helping the Body Fight the Natural Way


 


SUMMARY OF CLINICAL EVALUATIONS USING MARIANDINA THAT ARE UNDERWAY IN UGANDA, TANZANIA AND NIGERIA

 

BACKGROUND

In HIV management, nutritional is essential. The nutritional component comprises of carbohydrates, fats, proteins, vitamins and trace elements.  The carbohydrates cater for the daily energy requirement of the body, the virus and the opportunistic infections plus the energy required to fight these infections. The proteins are required to provide amino acids that are the building blocks for the body. The immune response also needs amino-acids as building blocks. In addition, the infections also need the amino-acids for their construction. On top of providing a source of energy fats and oil provide a solvent for vitamins like A, D, E, and E and also act as an appetiser as they dissolve flavors.

 

The demand for nutrients is increased by diseases like HIV.

 

NB: CD4 provides an indication that the cells in which the virus multiplies are not dying faster than they are made. It is a guide to show improvement of immunity. An increase in CD4 in HIV patients indicates an improved immunity.

 

(i) UGANDA CLINICAL TRIAL; Dr.James Kiyengo, Others  Dr.Kabugo, Dr.Kalinda

Title: The role of Mariandina A in the management of HIV patients in bombo Military  hospital Uganda in may 2006 to nov 06.

 

Patients by law with CD4 count over 250 units must be given ARVs. This law applies worldwide. Therefore the evaluation concentrated on the use of Mariandina A alongside ARVs.

 

CONCLUSION

1.      Mariandina A improves weight gain and prevents weight loss among patients on T30

2.      Mariandina A improves increase in CD 4 count among patients on T30

3.      Mariandina A does not change significantly the rate of occurance of opportunistic infections among HIV infected patients.

4.      Mariandina A reduces the death rate among patients on T30

 

RECOMMENDATIONS

Mariandina A should be given as a nutritional supplement to HIV patients on T30 to improve weight gain, improve CD4 increase and reduce the death rate

 

(ii) TANZANIA - A PRIVATE STUDY– Dr Fred Limbanga, Tanzania

Title:  The Effectiveness Of Mariandina Herbal Product In Treatment Of HIV / AIDS Cases. A private study on 10 patients over 3 months.

 

Mariandina ALONE was given to 7 patients who had a CD4 count of above 250 and so were not on ARVs. Mariandina was also gave it to 3 patients who qualified for ARVs under global law. The

CD4 was measured at month 1 and at month 3. The results show that in both cases, Mariandina helped and the CD4 count increased over the 3 month period indicating an increase in immunity.

 

•After 3 months the CD4 count of all the patients using Mariandina and Triomune (an ARV) was seen to increase.

After 3 months the CD4 count of all the patients using Mariandina alone was seen to increase.

 

Future Plans

•Long Term Research for at least 1 year is needed to make a proper follow up of CD4 and viral load before making conclusion

•Patients should continue taking the Mariandina tablets with or without Triomune for at least 12 months

•A larger number of patients is needed of different age groups, sex etc for research purposes.

 

 

 

 

(iii) NIGERIAN CLINICAL TRIAL – BREAST CANCER AND DIABETES

 

Neimeth commisioned Dr K C Tshasime MBBS, FWACP of the Group Medical Centre Cottage hospital to evalute Mariandina for a range of ailments in a single comparative product clinical evaluation trial. Although results for HIV and Hypertension are available and positive, this report only includes the results for the evaluation on Diabetes Mellitus and Breast cancer. A total of 10 patients. 5 control and 5 using their standard therapeutic drugs that they were on alongside Mariandina A, J and B.

 

- Breast cancer - 3 patients

- Diabetes Mellitus - 2 patients

 

IN SUMMARY THERE WERE THE FOLLOWING:

 

HepatoSpenomelgaly:-        There was a remarkable reduction in the sizes of the 

Spleen and Kidney in the Study Group by about 25% in comparison with the Control Group.

 

Weight:- There was a weight gain of 18% in the Study Group in comparison to the Control Group.

 

Laboratory Results:-            There was about 28% positive shift in all the Laboratory Indices recorded on the Study Group in comparison with the Control Group.

 

 

·        There were no significant changes in the Blood Pressure and Pulse readings of both the Study and Control Groups at Baseline and Study End.

 

·        Similarly there was no observed ECG changes for both the Study and Control Groups a Baseline And Study End.

 

·        There were no noticeable side effects recorded during this study.

 

CONCLUSION

This study has shown that with the Mariandina A and J Products when used as adjuncts in the management of Diabetes Mellitus and Breast Cancer in this study Group provided some beneficial effects to the subjects.

 

However due to the Study Size, Care should be taken in making any form of Claim with Regards to the Efficacy and Safety of the Mariandina A and J products in the management of the disease conditions in this study. Further pilot studies and results are expected in the next month to cover the other ailments that are not covered in this report.



(iv)  Evaluating the effect of Mariandina A and J on HIV potivie Patients at Nigerian Navy Hospital Ikeja
Nigeria.


(NB
: Evaluations are underway in Cameroon, Ghana, Malawi, Nigeria, Uganda, Kenya and Tanzania.)



NIGERIAN NAVY HOSPITAL OJO LAGOS

EVALUATING THE EFFECT OF MARIANDINA A AND J ON CD4 COUNT AMONG HIV POSITVE PERSONS 

 

*Dr Abu Daniel Echoga (MBBS, MPH FMCPH, FWACP.)Senior Consultant Community Physician/ Member ART Team NNH OJO

 

Dr TGS Epelle MBBS, FWACP Chief Consultant Paediatrician/ Team Leader ART Team NNH OJO

 

CONCLUSION

 

Mariandina A and J were administered to 25 HIV positive individuals with CD4 count above 250 cells/uL for a period of 3 months. Out of 23 due for evaluation, 17 were evaluated and 15 (88.2%) had appreciable increase in CD4 count after 3 months. The average CD4 was 609 compared to baseline of 465 cells/uL. The participants also gained weight and reported improvement in general well being. Forty percent of the participants complained of excessive rumbling in the stomach on initiation of treatment. This was however not severe enough to discontinue treatment with mariandina.

 

RECOMMENDATIONS

 

Based on the above findings, it is recommended that

 

1.         There is need for an expanded study to be conducted among larger numbers of HIV positive individuals with appropriate controls. The study could also be conducted over a longer period to determine if the immune boosting, building and antiviral activity as observed in this evaluation could be sustained for longer period.

 

2.         That mariandina A and J should be administered to HIV positive individuals whose clinical staging do not qualify them for ARV. It could also be given as adjunct treatment with ARV

 



-------------------------------------------------------------------------------------------------------------------

NIGERIAN EVALUATION

EVALUATING THE EFFECT OF MARIANDINA A AND J ON CD4 COUNT AMONG HIV POSITIVE PERSONS 

 

*Dr Abu Daniel Echoga (MBBS, MPH FMCPH, FWACP.)Senior Consultant Community Physician/ Member ART Team NNH OJO

 

Dr TGS Epelle MBBS, FWACP Chief Consultant Paediatrician/ Team Leader ART Team NNH OJO

 

Dr Y Rahman MBBS Medical Officer Member ART Team NNH OJO

 

SLt  Onah BMLS Lab Scientist NNH OJO

 

Mrs L Onwaeze RN RM Clinic Manager, IDC NNH OJO

 

* Principal Investigator

 

 

INTRODUCTION

 

Though Anti-Retroviral drugs are now available, the side effects and adverse reactions experienced by persons on these products is enormous. Further more, it would be desirable for persons leaving with HIV to stay healthy without ARVs. Thus any medications short of ARV that has no known adverse reactions or side effects would form an essential component in the management of HIV/AIDS.  It is for this purpose that this evaluation was conducted to determine the benefits of mariandina A and J to persons living with HIV/AIDS

Mariandina A is reported to contain advanced natural composition consisting of 28 natural herbs, vitamins and minerals and other rare elements which is capable of boosting the immune system, repair body cells and tissues. Mariandina J is also reported to be an advanced natural preparation containing 29 powerful herbs which detoxify and cleanse the body. It is believed that the herbs used for the preparation of Mariandina J  the capacity to inhibit viral activity

 

STUDY AREA

 

Nigerian Navy Hospital (NNH) Ojo started its operations in 1984 and was officially commissioned in March 1985.  It was designed and commissioned as a 110-bed hospital. The hospital is located inside the Nigerian Navy barracks (NNS WEY) in Amuwo-Odofin Local Government Area of Lagos State, South West Nigeria.

 

            The Hospital is the main referral hospital of the Nigerian Navy. Furthermore, the Police, other paramilitary organizations and federal civil servants within the area utilize its services. The hospital also extends its services to civilians within its neighbourhood.    Additionally, NNH Ojo assists in the training of different categories of health workers including Medical House officers.  The hospital bed occupancy rate at any point in time is above 80%.

 

The hospital services are organized into various departments. These consist of clinical units such as the Department of Medicine, Paediatric, Surgery, Obstetrics and Gynaecology and Dentistry. Others include Physiotherapy, Medical Laboratory, Pharmacy, Radio-diagnosis and Health Management Information Service departments. In addition, there are other clinical services departments such as Maternal and Child Health and clinical psychology.

 

The Hospital offers a comprehensive HIV/AIDS services and treatment programme funded by the Nigerian Ministry of Defence and US Department of Defence HIV/AIDS Programme. The services include the PMTCT clinic, HIV counseling and testing and the provision of antiretroviral treatment to HIV/AIDS patients. 

 

 

OBJECTIVE

 

The broad objective of this evaluation was to determine the benefits of Mariandina to persons living with HIV.

 

SPECIFIC OBJECTIVES

 

The specific objectives were

 

1.                   To determine the effect of Mariandina  A and J on CD4 count

2.                   To monitor  weight changes  in persons on  Mariandina A and J

3.                   To document side effects/adverse reactions of mariandina A and J

 

 

INCLUSION CRITERIA

 

HIV positive Persons attending antenatal clinic, VCT and Infectious Disease Clinic at the Nigerian Navy Hospital Ojo Lagos Nigeria were recruited based on the baseline CD4 count. The baseline CD4 count at the time of recruitment is 250 cell /ul or more. The individual must not be on ARV at the time of recruitment. Thereafter, informed consent was obtained through the signing of consent form.

 

 

EXCLUSION CRITERIA

 

Individuals with CD4 count of less than 250 cells/ul and those currently on ARV treatment.

 

ETHICAL REVIEW/APPROVAL

 

Ethical approval was obtained from the ARV treatment team of the Nigerian Navy Hospital Ojo after a thorough review of the protocol as well as extensive review of literature on the mariandina. Also, approval was obtained from the Directorate of Nigerian Navy Medical Services at the Naval Headquarters, Moloney, Lagos.

 

LIMITATIONS

 

Viral load testing facilities was not readily available to the researcher. The study is limited in scope due to number of persons recruited and the duration of follow up. 

 

METHODOLOGY

 

The participants were HIV positive individuals confirmed using western blot method. They were selected from clients attending the antenatal clinic, voluntary counseling and testing and infectious Disease Clinic at the Nigerian Navy Hospital Ojo. The CD4 count at the time of recruitment must not be less than 250 cells/ul. On recruitment, initial clinical evaluation was conducted to document the clinical status of the participant. The participants were subjected to physical examination. The weight of the participant at presentation was recorded. Thereafter, blood sample was collected to determine the baseline CD4, full blood count, liver function test electrolyte and urea. The recruitment was clinic based thus individuals were recruited over the period of three months from August to November 2006.

 

The participants were administered caplets of mariandina A and J. Each participant was given monthly supply of mariandina A and J with monthly follow up in the clinic. The participant takes one caplet each of mariandina A and J twice daily for a period of three months.  The follow up was used for adherence monitoring, clinical examination and documentation of observed side effect. In all, twenty five persons were administered mariandina A and J for a period of three months. The final clinical and laboratory evaluation was conducted at the end of 3 months on the medication.

 

RESULTS

 

Demographic Characteristics

 

The participants were 7 males and 18 females. The age range of the participants was 19 to 47 years. The average age of the participants was 31.4years.  Twenty three of the twenty five participants were due for evaluation at the time of report. Seventeen (73.9 %) out of twenty three turned up for final evaluation. Among the participants, evaluated, 13 (52%) were married, 9 (36%) were single and 3 (12%) were widows. The details are as shown in table 1

 

 

Table 1: Sex and Marital Status

Marital Status

Male

Female

Total

Married

4

9

13 (52%)

Single

3

6

9 (36%)

Widow (er)

Nil

3

3(12%)

Total

7 (28)

18(72%)

25 (100%)

 

 

 

 

Table 2: The Result of Baseline and Post treatment CD4 count and Weight among Participants

 

S/no

Name

ID No

Sex

Age (yrs)

Date Commenced

BL Wt(Kg)

BLCD4 (Cells/UL

3M wt(Kg)

3 M CD4(Cells/UL

Change in CD4

1

XX01

027/06

F

34

16/8/-22/11/06

68

470

74

835

365

2

XY01

218/06

M

44

16/8/06

85

330

90

425

95

3

XX02

200/06

F

44

23/8/06

55

290

60

387

97

4

XY02

203/06

M

32

23/8-22/11/06

75

470

72

808a

338

5

XX03

006/05

F

40

30/8/06

60

 440

64

501

61

6+

XX04

216/06

F

33

30/8/06

76

560

81

824

264

7+

XX05

055/06

F

29

18/10/06

75

642

79

897

255

8

XX06

219/06

F

26

21/10/06

50

460

60

580

120

9

XX07

109/06

F

29

1/11/06

55

290

60

429

139

10

XX08

100/06

F

23

8/11/06

64

 410

69

362

-48

11

XX09

151/06

F

29

15/11/06

61

455

64

370

-85

12

XY03

017/05

M

27

8/11/06

65

760

69

958

198

13

XX10

 

F

19

15/11/06

60

400

60

773

373

14+

XX11

110/06

F

34

30/8/06

62

400

68

459

59

15

XX12

124/06

F

30

27/9

71

 719  

74

761

42

16

XY04

121/06

M

47

13/9

88

370

105

650

280

17

XX13

152/07

F

25

18/1/07

54

442

55

332

-110

18

XX14

012/05

F

22

30/8/06

58

510

-

-

 

19

XX15

224/06

F

25

08/11

57

700

-

-

 

20

XX16

149/06

F

24

7/2/07

60

250

-

-

 

21

XY05

220/06

M

35

30/8/06

68

340

-

-

 

22

XY06

156/07

M

47

21/2/07

79

305

-

-

 

23

XX17

150/07

F

28

14/2/07

70

582

-

-

 

24

XX18

 

F

33

16/9/06

67

938

-

-

 

25

XX19

131/06

F

26

9/9/06

64

270

-

-

 

Average  Baseline and post treatment weight and CD4 for 17 evaluated participants

66.1

465

70.8

609

143.71

 

+Exposed to HART during PMTCT

 

 

CD4 Evaluation

 

Table 2 shows increase in CD4 among participants. The pre evaluation total CD4 count for the seventeen persons was 7,908 cells/uL with average of 465cells/uL. The 3- month post mariandina A and J treatment total CD4 for the seventeen participants was 10351 cells/uL with average of 609 cells/uL.  Three participants reported decrease in CD4 count while on mariandina A and J. The change in CD4 vary from -110 to 373 with average change of 143.71 cells/UL .

 

Weight gain

 

Table 2 shows total baseline weight of the participants. The average baseline weight of the seventeen participants is 66.1kg. The table also shows the post mariandina total weight for the seventeen participants. The post mariandina average weight for the seventeen participants is 70.8 kg. The weight gain among participants vary from nil to 17kg

 

Adverse Reactions

 

There were no reported serious adverse reactions on persons on Mariandina A and J during the period under review. However, three of the participants complained of rumbling in the stomach. Twelve of the seventeen reported change in the color of their urine from normal to deep yellow or green. 

 

DISCUSSION

 

Mariandina A and J are nutritional herbal formulations that had been used for over 10 years in Africa. The beneficial effect of the product in AIDS patients had been reported in the past. This evaluation was conducted to look at the effects of mariandina on CD4 and document any adverse reactions. Out of the total of 25 persons on mariandina A and J, 23 were due for evaluation having completed 3 months on the Mariandina A and J. only 17 returned for evaluation. Among those evaluated 88.2 percent showed remarkable improvement in the post treatment CD4 count. The average CD4 after 3 months on mariandina A and J was 608.88 compared to the baseline average CD4 of 465.17. The range of increase among individuals was from 42cells/uL to as high as 373cells/uL. The observed increase in CD4 among the participants could be attributed to the immune boosting and building effect of Mariandina A and J. Only 11.8 percent showed reduction in CD4 count. The overall  average of the change in CD4 was 143 cells/ul.

 

However, the three persons that had reduction in CD4 experienced weight increase and did not report any deterioration in their state of health.

 

All the participants reported increase in weight. The average post mariandina weight for the participants was 70.8 kg compared to the average baseline weight of 60.1 kg The weight increase range from nil to 17 kg The gain in weight noticed among participants could be attributed to the appetite stimulating effect of mariandina A and J. The majority of the participants reported increase in appetite while on mariandina. The appetite stimulating effect could be useful for persons with debilitating conditions and loss of appetite as in AIDS patient.

 

All the female participants reported improvement in their menstrual flow compared to pre mariandina treatment while the men reported improved vitality

 

All the participants reported change in urine color for amber to deep yellow or greenish appearance. The color improved to near normal with improved fluid intake. Forty percent of the participants complained of excessive rumbling in the stomach on initiation of treatment. The rumbling was severe in one participant that she had to stop medication before reaching the clinic. This however, stopped after about one week on the medication.

 

The natural history of HIV suggests increase in CD4 count as part of the initial body immune response to early infection. This is usually followed by sustained reduction in CD4 in majority of persons without intervention. The advent of ARV has reversed this trend with improvement in immune response and reduction in viral load. The observed effect of mariandina A and J in this evaluation suggests presence of some anti retroviral ingredient in the product. This may be responsible for the improvement in the state of general well being experienced by the participants while on the product. The observed increase in CD4 in the post treatment evaluation could be explained by the reported immune boosting and building effect of the products. Considering the improvement in both the CD4 count and general state of well being in participants in this evaluation, the product could be useful as adjunct treatment in persons already on ARV. It would also be beneficial as single treatment for persons not yet qualify for ARV. However, there is need for follow up monitoring of the viral load at regular intervals.  There is need for an expanded study to be conducted among larger numbers of HIV positive individuals with appropriate controls. The study could also be conducted over a longer period to determine if the immune boosting, building and antiviral activity as observed in this evaluation could be sustained for longer period. Meanwhile it is recommended that mariandina A and J could be administered to HIV positive individuals whose clinical staging do not qualify them for ARV. It could also be given as adjunct treatment with ARV

 

CONCLUSION

 

Mariandina A and J were administered to 25 HIV positive individuals with CD4 count above 250 cells/uL for a period of 3 months. Out of 23 due for evaluation, 17 were evaluated and 15 (88.2%) had appreciable increase in CD4 count after 3 months. The average CD4 was 609 compared to baseline of 465 cells/uL. The participants also gained weight and reported improvement in general well being. Forty percent of the participants complained of excessive rumbling in the stomach on initiation of treatment. This was however not severe enough to discontinue treatment with mariandina.

 

RECOMMENDATIONS

 

Based on the above findings, it is recommended that

 

1.         There is need for an expanded study to be conducted among larger numbers of HIV positive individuals with appropriate controls. The study could also be conducted over a longer period to determine if the immune boosting, building and antiviral activity as observed in this evaluation could be sustained for longer period.

 

2.         That mariandina A and J should be administered to HIV positive individuals whose clinical staging do not qualify them for ARV. It could also be given as adjunct treatment with ARV

 

 



EVALUATION OF MARIANDINA A, J AND B PRODUCTS
IN THE MANAGEMENT OF HIV/AIDS, DIABETES

MELLITUS, BREAST CANCER HYPERTENSION AND RENAL/URINARY TRACT DISEASES

IN A SINGLE COMPARATIVE PRODUCT CLINICAL EVALUATION TRIAL

 

 

 

 

 

INVESTIGATOR:                                              Dr K. C. Tshasime MBBS, FWACP Group Medical Centre / Cottage Hospital Aba/Azumiri, Abia State, NIGERIA

 

 

 

 

 

 

CENTRE:                                                                    Group Medical Centre Aba. Cottage Hospital, Azumiri, NIGERIA

 

 

 

 

 

 

GLOBAL CO-ORDINATOR:          Neimeth International Pharmaceuticals, Plc. No. 1 Henry Carr Street, Ikeja, Lagos, Nigeria.

 

 


 

 

 

Summary:-

 

Mariandina A, B and J are advanced unique Natural Product Formulations consisting of Natural Products, Antioxidants, Vitamins, Minerals, herbs and minute amounts of Rare elements thought to boost the body immune system, Repair body cells and Tissues, Cleansing of body toxic substances produced during metabolism (detoxification), Stress relief, increased blood circulation especially in the Brain, Sexual organs and the heart to rejuvenate functionality with improved Energy Levels with overall general bodily well being.

 

Specifically,

 

1.      Mariandina A is an advanced unique natural Product formulation consisting of natural products antioxidants, vitamins, minerals, herbs and minute amounts of rare elements. Including; Vitamin C, A, E, B12, Folic acid, Citrus Bioflavanoids, Copper, Iodine, Niacin, Biotin, Calcium, Zinc, Iron, Selenium, Manganese, Ginseng + and is in tablets and capsule forms.

 

 

2.     Mariandina B is an advanced natural product formulation consisting of natural herbs and vitamins E, C,

3.      Siberian Ginseng Powder, Alfalfa leaf, Bee pollen, Golden seal Root, Gotu Kola, Betacarotene, Kola nut, Liquorice root, Hawthorn Berry, Capsicum, Yellow Dock leaf, Di-basic Calcium phosphate, Echinacea, Purpurea, Ginkgo Biloba leaf, Garlic, Co-enzyme Q-10, Guarana and is only in tablet form.

 

 

3.   Mariandina J is an advanced natural product formulation consisting of 29 

      Natural herbal ingredients that have been known for generations of use in  

      Africa and is in tablets and capsule forms.

  

 

 

Objectives of the Study:-

 

1. The aim of this study is to evaluate the Efficacy and Safety of Mariandina A, J,   

     and B Natural Products in the management of Debilitating Disease States of  

     Diabetes Mellitus, HIV/AIDS, Malignant Hypertension, Breast Cancer, Renal

     and Urinary Tract Infections at the Symptomatic Indices of Presentations,

     Physical Examinations, Biochemistry, Microbiology, Serological and

     Histopathology Evaluations.

 

2.  To re-confirm claim and dose regimen.

 

 

 

Specifically this study considered only subjects suffering from diabetes Mellitus and Breast Cancer.

 

 

 


Type of Study:-

 

Single Comparative Product Clinical Evaluation Study with Parallel Control Group Study in which these Mariandina A, J and B Natural Products would be evaluated. All the subjects will be concurrently be on their known Therapeutic Drugs they are currently on for their respective disease conditions.

 

 

Number of Subjects for the Study:-

 

The total number of Subjects for this study was 10 (Ten) in Groups of 5(Five) for the control and 5 (Five) to be on the Mariandina A, and B.

 

It however should be noted that this Study Population of 10 (Ten) is statistically no relevant but could serve as pilot study extrapolations for future statistically relevant studies.

 

We wanted to recruit additional subjects for this study as subject drop outs were anticipated. However, there were no subject dropouts due to mainly the duration of this Study which was 8 (Eight) weeks and the fact that 70% of the subjects were on hospital admission for the duration of the study.

 

 

Methods:-

 

Patient Recruitment into the Study was done from the patient pool of the hospital of not less than two years attendance. The Hospital Governing Board and Management Approved the Protocol and Ethics of this Evaluation Study.

 

All subjects are known patients with Debilitating Terminal Disease Conditions of Diabetes Mellitus and Breast Cancer being managed by this Medical Centre for a minimum of two years.

 

All Subjects were adults aged 35 years and above with the mean age of the participants in study group being 56.2 years while the control group was 59.15. There was no statistically significant difference between the mean ages of the two groups P = 0.3016 (P=NS).

 

Subjects would be allowed to be on whatever standardized medications that they were presently on, but there would be a run-in period of 2 weeks during which the subjects medications would be streamlined and a standardised for uniformity and control studies and evaluation while there would be a 2 weeks washout period during which there would be a discontinuation of the use of the Mariandina A, J and B products.

 

All subjects were to be closely observed and monitored. Cost of this study which is exclusive of Medications, Investigations, Honorarium was borne by NEIMETH.

 

The Subjects were on treatment for 6 weeks. They were randomised to the study group and control group of 5’s to receive either their disease conditions therapeutic drugs alone as control and with the Mariandina A, J and B products in addition as study group.

Group comparison was done using Student t-test and Paired t-test. Level of significance was set at 0.05.

 

Confirmatory diagnosis of the subjects specific disease condition of Breast cancer and Diabetes Mellitus respectively were again made and established at their symptomatic indices plus laboratory  investigations.

 

The following Laboratory investigations were conducted before commencement of this study (baseline) and at end of study as total of 15ml of blood was taken by vene-puncture.

 

Fasting Blood Sugar

GTT

Full Blood count

Urinalysis

LFT

Electrolyte, Urea and Creatinine

Haemotocrit

Lipids

 

Baseline characteristics of the subjects like age, gender, body weight and height were done and recorded before commencement of and after the study.

 

Compliance was assessed by pill counting and this was exact as patients were all on hospital admission.

 

Patients may withdraw from this study if either the medication of Mariandina A, J and B products cannot be tolerated or due to serious adverse reactions, poor compliance or other serious concomitant illness or if subject desires to withdraw.

 

Consent was FREELY obtained from the subjects and countersigned by relatives and relations as standard. Only subjects who agree voluntarily to participate were recruited into the study. Those who refused to participate did not suffer any prejudice. The study maintained the highest level of confidentiality as is required in such studies as the identity of the subjects were kept secret and can only be divulged on written consent of the subject.

 

Patients with Renal and Hepatic diseases, Heart Failure, Stroke, Psychiatric disorders and abnormal Haematology Chemistry were EXCLUDED from this study. Neither the participants nor the investigators influenced the composition of the respective study and control groups as this was randomised.

 

All adverse events occurring in the course of the trial were to be recorded in the CASE Report Form. An adverse event was defined as any undesirable symptom sign or medical condition occurring after starting study medication whether considered drug related or not.

 

4 subjects on the study group were place on Mariandina A and J combination therapy while one subject in the study group was placed on Mariandina B as shown in the therapeutic management Table 1.

 

Table 1

 

 

No.

Disease Condition

Study Group

Control Group

Sex

 

2

Diabetes Mellitus

Mariandina A and J

Nil

Males

 

2

Breast Cancer

Mariandina A and J

Nil

Females

 

1

Breast Cancer

Mariandina B

Nil

Females

 

 

 

Case Record Form (CRF) had the following data:

 

Name                                                                            

Study ID No.

Hospital No.

Date of Enrolment

Date of Birth

Age

Sex

Weight

Height

Temperature

Next of Kin/ Guardian

Address

Duration of Illness / how long since Confirmatory Diagnosis

 

 

Symptoms History

 

Fever

Vomiting

Diarrhoea

Pains

Irritability

Agitation

Appetite/ Anorexia

Palpitation

Insomnia

Apathy

Other Complaints

 

 

Past Medical History

 

History of any concomitant illness like hypertension etc.

History of drug allergy, name of drug and duration.

Treatment History

 

Drugs in use for present Medical condition and duration.

 

 

Physical Examinations With dates and times of examination were conducted for;

 

Pallor

Icterus

Skin                                                      - Flaky

Cardiovascular System               - Pulse, Heart Beat, Heart Sounds, Rhythm

Respiratory System                               - Respiratory Rate, Breath Sound

Abdomen                                              - Liver Size (below coastal margin), Spleen size 

                                                        and kidneys

Muscle Tone                                          - Normal, Hypotonia, Hypertonia

Eyes                                                     - Conjunctivitis, Discharge

Lymph Nodes                                        - Presence of Metastasis, Lymph Node Sizes

Ears                                                     - Any Discharge

 

Data Management and Analysis:-

 

All data obtained was coded and keyed into a computer running the EPI-INFO

version 6 program for analysis. Comparison was done using Student t-test for

parameters between the groups and paired t-test for parameters within the group.

Significance was set at P. <0.05.

 

 

RESULT:-

 

10 (Ten) participants were recruited into the study as 5 (five) in study group and

5(Five) in control group to take treatment over a 6 week period. Since all subjects

were on hospital admission, none was lost during the study as the 10 were

evaluable.

 

The mean age of the participants in study group was 56.2 years while it was 59.15

in the control group with age range between 35 and 70 years. There were 2 males

and 3 females in the study group and 1 male and 4 females in the control group.

There was no statistically significant difference between the mean ages of the two

groups P=0.3016 (P = NS) as shown in Table 1.

 

There were noticeable significant differences form the 3 to 6 weeks in both groups.

Table 3 shows laboratory parameters of the subjects before and at the end of the

study.

 

There were no significant changes observed in the haematological and laboratory

parameters before and after the trial if the patient in the study group on

Mariandina B products.

 

 

Table 1: Age Distribution of Participants in both Groups

 

Asafdadfadfad                                                      Age Groups

Study Group

Control Group

35 - 45

1

1

46 – 55

1

1

56 – 65

2

1

66 – 75

1

1

Above 75

Nil

1

Total

5

5

 

 

Table 2: Dose Regimen

 

S/No.

Subject

Mariandina A

Mariandina J

Mariandina B

1.

Male

Caps. II tds daily

Caps. II tds daily

Caps. II tds daily

 

2.

Female

Caps. II tds daily

Caps. II tds daily

Caps. II tds daily

 

 

 

Note: Any patients who show any form of adverse reaction in the use of these Mariandina products was excluded immediately

 

 

IN SUMMARY THERE WERE THE FOLLOWING:

 

HepatoSpenomelgaly:-    There was a remarkable reduction in the sizes of the 

                                                Spleen and Kidney in the Study Group by about 25% in

                                                comparison with the Control Group.

 

Weight:-                                    There was a weight gain of about 18% in the Study

Group in comparison to the Control Group.

 

Laboratory Results:-       There was about 28% positive shift in all the Laboratory

Indices recorded on the Study Group in comparison with the Control Group.

 

 

·        There were no significant changes in the Blood Pressure and Pulse readings of both the Study and Control Groups at Baseline and Study End.

 

·        Similarly there was no observed ECG changes for both the Study and Control Groups a Baseline And Study End.

 

·        There were no noticeable side effects recorded during this study.

 

This study has shown that with the Mariandina A and J Products when used as adjuncts in the management of Diabetes Mellitus and Breast Cancer in this study Group provided some beneficial effects to the subjects.

However due to the Study Size, Care should be taken in making any form of Claim with Regards to the Efficacy and Safety of the Mariandina A and J products in the management of the disease conditions in this study.

 

 

Table 4: Laboratory Parameters of the Subjects at Baseline and Study End

 

VARIABLES

Study Group

Baseline

Study End

Control Group

Baseline

Study End

 

P Value

Inter group

P Value

Intra group

Random

BG

136.75+ 13.1

125.09+5.0

 

134.25+8.72

132.4+8.22

0.58819

0.3497

Study Group 0.0511

Cont Group 0.1856

Albumin

94.4+14.9

82.6+2.4

 

97.6+6.2

94.55+8.36

0.3646

0.7844

Study Group 0.0698

Cont Group 0.0422*

MCV/µ

 

66.42+5.97

78.36+7.3

65.26+5.3

66.5+4.05

0.6819

0.4149

Study Group 0.0277*

Cont Group 0.6509

Alk Phos IU

98.73+18.1

89.09+12.7

103.55+27.82

105.44+28.70

 

0.5298

0.3268

Study Group 0.2177

Cont Group 0.6509

 

Cholesterol mg%

165.95+30.32

148.2+19.22

159.05+23.9

151.90+23.75

0.5744

0.9114

Study Group 0.5605

Cont Group 0.7185

 

LDL mg%

98.75+21.61

90.5+17.38

96.0+19.4

94.90+24.8

0.7084

0.9752

Study Group 0.2701

Cont Group 0.4347

 

HDL mg%

46.75+8.55

46.75+18.12

42.83+11.43

44.18+13.09

0.4555

0.7032

Study Group 0.3256

Cont Group 0.0791

 

TG mg%

86.7+14.18

82.5+17.7

90.88+23.6

95.09+28.8

0.7177

0.4396

Study Group 0.9324

Cont Group 0.8856

 

Urea mg%

24.26+5.89

25.27+6.4

24.7+4.05

26.55+7.11

0.9016

0.7749

Study Group 0.8258

Cont Group 0.8485

 

Creatinine mg%

0.86+0.22

0.82+0.16

0.89+0.2

0.89+0.21

0.7087

0.1359

Study Group 0.5042

Cont Group 0.6141

 

Sodium Meq/l

134.0+4.4

131.2+3.06

129.5+8.24

128.4+7.9

0.0715

0.2992

Study Group 0.0256

Cont Group 0.0901

 

Potassium Meq/l

4.0+5.8

3.35+0.31

3.8+0.75

3.37+0.51

0.5625

0.921

Study Group 0.0001

Cont Group 0.0211

 

PCV %

33.82+4.92

39.27+2.24

32.4+8.3

30.33+4.8

0.5155

0.798

Study Group 0.0824

Cont Group 0.7632

WBC/ cmm3

14,894+833

12,813+1,989

15,146+992

16,255+2,237

0.4399

0.01*

Study Group 0.9148

Cont Group 0.2354

FBG mg/dl

96.05+12.14

105+47.27

104.73+27

102.7+28.7

0.686

0.8492

Study Group 0.1846

Cont Group 0.340

 

CONCLUSION

 

An Evaluation of at least 1 year is needed to make a proper deduction and follow of the Study Subjects is recommended before making equivocal deductions and conclusions.

 

The Study population should be increased to at least 300 patients of different age groups and sexes to have a statistically relevant number for deductions.

 

It is advisable that the Subjects continue taking the Mariandina tablets for at least 12 months due to the disease conditions under study.



EVALUATING THE EFFECT OF MARIANDINA A AND J ON CD4 COUNT AMONG HIV POSITVE PERSONS 

 

*Dr Abu Daniel Echoga (MBBS, MPH FMCPH, FWACP.)Senior Consultant Community Physician/ Member ART Team NNH OJO

 

Dr TGS Epelle MBBS, FWACP Chief Consultant Paediatrician/ Team Leader ART Team NNH OJO

 

Dr Y Rahman MBBS Medical Officer Member ART Team NNH OJO

 

SLt  Onah BMLS Lab Scientist NNH OJO

 

Mrs L Onwaeze RN RM Clinic Manager, IDC NNH OJO

 

* Principal Investigator

 

 

INTRODUCTION

 

Though Anti-Retroviral drugs are now available, the side effects and adverse reactions experienced by persons on these products is enormous. Further more, it would be desirable for persons leaving with HIV to stay healthy without ARVs. Thus any medications short of ARV that has no known adverse reactions or side effects would form an essential component in the management of HIV/AIDS.  It is for this purpose that this evaluation was conducted to determine the benefits of mariandina A and J to persons living with HIV/AIDS

Mariandina A is reported to contain advanced natural composition consisting of 28 natural herbs, vitamins and minerals and other rare elements which is capable of boosting the immune system, repair body cells and tissues. Mariandina J is also reported to be an advanced natural preparation containing 29 powerful herbs which detoxify and cleanse the body. It is believed that the herbs used for the preparation of Mariandina J  the capacity to inhibit viral activity

 

STUDY AREA

 

Nigerian Navy Hospital (NNH) Ojo started its operations in 1984 and was officially commissioned in March 1985.  It was designed and commissioned as a 110-bed hospital. The hospital is located inside the Nigerian Navy barracks (NNS WEY) in Amuwo-Odofin Local Government Area of Lagos State, South West Nigeria.

 

            The Hospital is the main referral hospital of the Nigerian Navy. Furthermore, the Police, other paramilitary organizations and federal civil servants within the area utilize its services. The hospital also extends its services to civilians within its neighbourhood.    Additionally, NNH Ojo assists in the training of different categories of health workers including Medical House officers.  The hospital bed occupancy rate at any point in time is above 80%.

 

The hospital services are organized into various departments. These consist of clinical units such as the Department of Medicine, Paediatric, Surgery, Obstetrics and Gynaecology and Dentistry. Others include Physiotherapy, Medical Laboratory, Pharmacy, Radio-diagnosis and Health Management Information Service departments. In addition, there are other clinical services departments such as Maternal and Child Health and clinical psychology.

 

The Hospital offers a comprehensive HIV/AIDS services and treatment programme funded by the Nigerian Ministry of Defence and US Department of Defence HIV/AIDS Programme. The services include the PMTCT clinic, HIV counseling and testing and the provision of antiretroviral treatment to HIV/AIDS patients. 

 

 

OBJECTIVE

 

The broad objective of this evaluation was to determine the benefits of Mariandina to persons living with HIV.

 

SPECIFIC OBJECTIVES

 

The specific objectives were

 

1.                  To determine the effect of Mariandina  A and J on CD4 count

2.                  To monitor  weight changes  in persons on  Mariandina A and J

3.                  To document side effects/adverse reactions of mariandina A and J

 

 

INCLUSION CRITERIA

 

HIV positive Persons attending antenatal clinic, VCT and Infectious Disease Clinic at the Nigerian Navy Hospital Ojo Lagos Nigeria were recruited based on the baseline CD4 count. The baseline CD4 count at the time of recruitment is 250 cell /ul or more. The individual must not be on ARV at the time of recruitment. Thereafter, informed consent was obtained through the signing of consent form.

 

 

EXCLUSION CRITERIA

 

Individuals with CD4 count of less than 250 cells/ul and those currently on ARV treatment.

 

ETHICAL REVIEW/APPROVAL

 

Ethical approval was obtained from the ARV treatment team of the Nigerian Navy Hospital Ojo after a thorough review of the protocol as well as extensive review of literature on the mariandina. Also, approval was obtained from the Directorate of Nigerian Navy Medical Services at the Naval Headquarters, Moloney, Lagos.

 

LIMITATIONS

 

Viral load testing facilities was not readily available to the researcher. The study is limited in scope due to number of persons recruited and the duration of follow up. 

 

METHODOLOGY

 

The participants were HIV positive individuals confirmed using western blot method. They were selected from clients attending the antenatal clinic, voluntary counseling and testing and infectious Disease Clinic at the Nigerian Navy Hospital Ojo. The CD4 count at the time of recruitment must not be less than 250 cells/ul. On recruitment, initial clinical evaluation was conducted to document the clinical status of the participant. The participants were subjected to physical examination. The weight of the participant at presentation was recorded. Thereafter, blood sample was collected to determine the baseline CD4, full blood count, liver function test electrolyte and urea. The recruitment was clinic based thus individuals were recruited over the period of three months from August to November 2006.

 

The participants were administered caplets of mariandina A and J. Each participant was given monthly supply of mariandina A and J with monthly follow up in the clinic. The participant takes one caplet each of mariandina A and J twice daily for a period of three months.  The follow up was used for adherence monitoring, clinical examination and documentation of observed side effect. In all, twenty five persons were administered mariandina A and J for a period of three months. The final clinical and laboratory evaluation was conducted at the end of 3 months on the medication.

 

RESULTS

 

Demographic Characteristics

 

The participants were 7 males and 18 females. The age range of the participants was 19 to 47 years. The average age of the participants was 31.4years.  Twenty three of the twenty five participants were due for evaluation at the time of report. Seventeen (73.9 %) out of twenty three turned up for final evaluation. Among the participants, evaluated, 13 (52%) were married, 9 (36%) were single and 3 (12%) were widows. The details are as shown in table 1

 

 

Table 1: Sex and Marital Status

Marital Status

Male

Female

Total

Married

4

9

13 (52%)

Single

3

6

9 (36%)

Widow (er)

Nil

3

3(12%)

Total

7 (28)

18(72%)

25 (100%)

 

 

 

 

Table 2: The Result of Baseline and Post treatment CD4 count and Weight among Participants

 

S/no

Name

ID No

Sex

Age (yrs)

Date Commenced

BL Wt(Kg)

BLCD4 (Cells/UL

3M wt(Kg)

3 M CD4(Cells/UL

Change in CD4

1

XX01

027/06

F

34

16/8/-22/11/06

68

470

74

835

365

2

XY01

218/06

M

44

16/8/06

85

330

90

425

95

3

XX02

200/06

F

44

23/8/06

55

290

60

387

97

4

XY02

203/06

M

32

23/8-22/11/06

75

470

72

808a

338

5

XX03

006/05

F

40

30/8/06

60