“Helping the Body Fight the
SUMMARY OF CLINICAL EVALUATIONS USING MARIANDINA THAT ARE UNDERWAY IN
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.
Title: The role of Mariandina A in the management of HIV patients in bombo Military hospital
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
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.
•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.
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
(NB: Evaluations are underway in
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
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
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
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
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
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 |
|
85 |
330 |
90 |
425 |
95 |
|
3 |
XX02 |
200/06 |
F |
44 |
|
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 |
|
60 |
440 |
64 |
501 |
61 |
|
6+ |
XX04 |
216/06 |
F |
33 |
|
76 |
560 |
81 |
824 |
264 |
|
7+ |
XX05 |
055/06 |
F |
29 |
|
75 |
642 |
79 |
897 |
255 |
|
8 |
XX06 |
219/06 |
F |
26 |
|
50 |
460 |
60 |
580 |
120 |
|
9 |
XX07 |
109/06 |
F |
29 |
|
55 |
290 |
60 |
429 |
139 |
|
10 |
XX08 |
100/06 |
F |
23 |
|
64 |
410 |
69 |
362 |
-48 |
|
11 |
XX09 |
151/06 |
F |
29 |
|
61 |
455 |
64 |
370 |
-85 |
|
12 |
XY03 |
017/05 |
M |
27 |
|
65 |
760 |
69 |
958 |
198 |
|
13 |
XX10 |
|
F |
19 |
|
60 |
400 |
60 |
773 |
373 |
|
14+ |
XX11 |
110/06 |
F |
34 |
|
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 |
|
54 |
442 |
55 |
332 |
-110 |
|
18 |
XX14 |
012/05 |
F |
22 |
|
58 |
510 |
- |
- |
|
|
19 |
XX15 |
224/06 |
F |
25 |
08/11 |
57 |
700 |
- |
- |
|
|
20 |
XX16 |
149/06 |
F |
24 |
|
60 |
250 |
- |
- |
|
|
21 |
XY05 |
220/06 |
M |
35 |
|
68 |
340 |
- |
- |
|
|
22 |
XY06 |
156/07 |
M |
47 |
|
79 |
305 |
- |
- |
|
|
23 |
XX17 |
150/07 |
F |
28 |
|
70 |
582 |
- |
- |
|
|
24 |
XX18 |
|
F |
33 |
|
67 |
938 |
- |
- |
|
|
25 |
XX19 |
131/06 |
F |
26 |
|
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
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,
CENTRE: Group Medical Centre
GLOBAL CO-ORDINATOR: Neimeth International Pharmaceuticals, Plc.
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
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
History of any concomitant illness like hypertension etc.
History of drug allergy, name of drug and duration.
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 -
Eyes - Conjunctivitis, Discharge
Lymph Nodes - Presence of Metastasis, Lymph Node Sizes
Ears - Any Discharge
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.
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.
|
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 |
|
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.
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
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,
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 |
|
85 |
330 |
90 |
425 |
95 |
|
3 |
XX02 |
200/06 |
F |
44 |
|
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 |
|
60 |