| CTRI Number |
CTRI/2017/09/009887 [Registered on: 22/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on Madhumeha (Type-2 Diabetes mellitus) with Mamajjaka ghanavati |
|
Scientific Title of Study
|
Clinical evaluation of Mamajjaka ghanavati in the management of Madhumeha(Type II Diabetes mellitus) |
| Trial Acronym |
MGV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShubhashree MN |
| Designation |
Research Officer(Ay) |
| Affiliation |
Regional Ayurveda Research Institute for Metabolic disorders |
| Address |
Regional Ayurveda Research Institute for Metabolic disorders Under
CCRAS Min of AYUSH Govt Central Pharmacy Annexe Near
Ashoka Pillar Jayanagar Bangalore -11
Bangalore
KARNATAKA
560011
India |
| Phone |
9448016968 |
| Fax |
080-26562030 |
| Email |
shubhathejas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShubhashree MN |
| Designation |
Research Officer(Ay) |
| Affiliation |
Regional Ayurveda Research Institute for Metabolic disorders |
| Address |
Regional Ayurveda Research Institute for Metabolic disorders Under
CCRAS Min of AYUSH Govt Central Pharmacy Annexe Near
Ashoka Pillar Jayanagar Bangalore -11
Bangalore
KARNATAKA
560011
India |
| Phone |
9448016968 |
| Fax |
080-26562030 |
| Email |
shubhathejas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShubhashree MN |
| Designation |
Research Officer(Ay) |
| Affiliation |
Regional Ayurveda Research Institute for Metabolic disorders |
| Address |
Regional Ayurveda Research Institute for Metabolic disorders Under
CCRAS Min of AYUSH Govt Central Pharmacy Annexe Near
Ashoka Pillar Jayanagar Bangalore -11
Bangalore
KARNATAKA
560011
India |
| Phone |
9448016968 |
| Fax |
080-26562030 |
| Email |
shubhathejas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council of Research in Ayurvedic Sciences, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 ( India )
Telephone : 91-011-28525862/28525897/28525852
Fax : 91-011-28520748/28525959 (Office of the DG) |
|
|
Primary Sponsor
|
| Name |
Central Council of Research in Ayurvedic Sciences |
| Address |
CCRAS, Ministry of AYUSH, Govt of India, Jawaharlal Nehru Bharatiya Evam Homeopathy Anusandhan Bhawan, No-61-65,Institutional Area, Opp "D" Block,Janakpuri, New Delhi 110056 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrBikartan Das |
National research Institute of Ayurveda Drug Development (NRIADD), |
Near Union Bank, Ghatikia, Bharatpur, Bhubaneswar, Odisha 751003
Khordha
ORISSA |
9438731606
dasbikartan@gmail.com |
| Dr GKSwamy |
National Veterinary Ayurveda Research Institute & Hospital |
INS-106, Sector-25, Indira Nagar, Lucknow-226016
Barabanki
UTTAR PRADESH |
9445207323
drgkswamy@gmail.com |
| DrShubhashree MN |
Regional Ayurveda Research Institute for Metabolic disorders |
Room No 2,Clinical Section,P.C.Road, Tulsithota,Bangalore -53.
Head Office- Govt Central Pharmacy Annexe, Near Ashoka Pillar, Jayanagar,Bangalore-11
Bangalore
KARNATAKA |
9448016968
080-26562030
shubhathejas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bangalore |
Approved |
| Institutional Ethics Committee, Bhuvaneshwar |
Approved |
| Institutional Ethics Committee, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetics aged between 35 to 65 years. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mamajjaka Ghana Vati |
Dose-2tablets(500mg each) bd
Dosage form- Tablet
Route and time of administration-Oral, 8am & 8pm
Vehicle-Lukewarm water
Duration of administration- 3 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Diabetics aged between 35 to 65 years.
2.Patients who are diagnosed to be Type II Diabetics by having Glycosylated Haemoglobin (HbA1c) between 6.5% - 9% or BS-F between 126 mg% - 200 mg% or BS-PP / Random between 200 mg% - 250 mg%.
3. Willing to participate and able to provide signed informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.
2. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
3.Hypertensive patients (> 140 / 90 mm Hg).
Symptomatic patient with clinical evidence of Heart failure.
4.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
5. Pregnant / Lactating women.
6. Patient on steroids, oral contraceptive pills or estrogens replacement therapy.
7. Alcoholics and/or drug abusers.
8.Patients with evidence of malignancy
9.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
10.H/o hypersensitivity to any of the trial drugs or their ingredients.
11.Patients who have completed participation in any other clinical trial during the past six (06) months.
12.Any other condition which the Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Glycosylated haemoglobin (HbA1c%) |
0 day(Baseline) and 84th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in Blood sugar Fasting (10-12 hrs after dinner) and Post - Prandial. (100-120 minutes after breakfast)
2.Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ)
3.Changes in the quality of life of the patients by using SF-36 (RAND) Health related QoL Survey questionnaire |
1. and 2. - At base line, at the end of 4 weeks, 8 weeks & 12 weeks.
3.At baseline and at the end of 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/05/2016 |
| Date of Study Completion (India) |
25/07/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL, Data of the clinical trial under review |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes mellitus (DM) is the third killer of the
mankind and it is one of the most challenging diseases facing health care
professionals today1. It is comparable to Madhumeha2.
Conventional agents are being used to control diabetes along with lifestyle management.
To date, over 400
traditional plant treatments for diabetes have been reported, although only a
small number of these have received scientific and medical evaluation to assess
their efficacy. The hypoglycemic effect of some herbal extracts has been
confirmed in human and animal models of type-2 diabetes. The World Health Organization Expert Committee on
diabetes has recommended that traditional medicinal herbs be further
investigated 3. Ayurvedic drugs not only have Pramehagna(antidiabetic),
but also have Rasayana (Immunomodulator) properties. This clinical trial
focuses on the validation of the safety
& efficacy of the Ayurvedic formulation Mamajjaka ghanavati . The drug Mamajjaka ghanavati contains Mamajjaka (Enicostemma littorale) extract-8 parts, 2 parts each of Mamajjaka
(Enicostemma littorale) Churna , Katuki (Picrorrhiza kurroa ) Pippali (Piper longum ) and Ativisha
(Aconitum heterophyllum). Mamajjaka (Enicostemma littorale) is
mentioned in Shodhala Nighantu (12thcentury) in Lakshmanadi varga 4. Mamajjaka
(Enicostemma littorale) has antidiabetic5 and antioxidant properties6. Shukla & Shukla concluded
that E. littorale extract for 45 days significantly reduced
hyperglycemia in type 2 diabetes mellitus. Enicostemma littorale possess potential antidiabetic
activity and improves lipid profile at a small dose of 0.5 g/kg7. Ativisha
(Aconitum heterophyllum) is one of the
bitter constituents, which is described in Ayurveda, as an effective drug in
noninsulin dependant Diabetes8. Ethanolic extract of Piper longum
(PLEFet) has
shown significant anti hyperglycemic, anti lipid peroxidative
and antioxidant effects in diabetic rats. It has also corrected the metabolic
alterations observed by the activities of several carbohydrate metabolizing
enzymes. The anti hyperglycemic effect of PLEFet has been compared
to that of the standard reference drug glibenclamide 9. Katuki (Picrorhiza kurroa) has been stated to be a
promising strategy for the treatment of diabetic nephropathy10.
Picrorhiza kurroa is hepatoprotective, antioxidant and hypolipidemic
drug 11. The current clinical
trial focuses on Ayurvedic drug preparation used in the treatment of diabetes
mellitus, a major non-communicable disease leading to huge economic losses. Bibliography
1.
Qi LW
et al. Anti-diabetic agents from natural products--an update from 2004 to 2009.
Curr Top Med Chem. 2010;
10(4):434-57. 2.
Clinical Research Protocols for
Traditional Health sciences, Central Council of Research in Ayurvedic Sciences,
Dept of AYUSH, Govt of India, New Delhi 2010, pg 459. 3.
Manisha Modak et al Indian
Herbs and Herbal Drugs Used for the Treatment of Diabetes J Clin Biochem Nutr. 2007 May; 40(3): 163–173. 4.
P
V Sharma.(ed). Sodala Nighantu of Vaidyachary Sodala, 1st ed.
Baroda: Oriental institute; 1978.,Lakshmanadi varga. 5.
Vijayvargia R
et al, Hypoglycemic effect of aqueous extract of Enicostemma littorale Blume
(chhota chirayata) on alloxan induced diabetes mellitus in rats. Indian J Exp Biol. 2000
Aug; 38(8):781-4. 6.
Rajamani
Saranya et al, Pharmacognosy of
Enicostemma littorale: A review, Asian Pacific Journal of Tropical Biomedicine,
Asian Pac J Trop Biomed 2013; 3(1): 79-84 7.
Shukla
Amarnath, Shukla HM. Single blind placebo controlled clinical evaluation of Mamajjaka ghanvati in prameha with special
reference to diabetes mellitus. Journal of Ayurveda and Holistic Medicine, 2013; 1(5): 11-9. 8.
M.D.
Ukani, N.K Mehta and D.D Nanavati, Aconitum Heterophyllum (Ativisha) In
Ayurveda, Ancient Science of life Vol. No XVI 2 Oct 1996, Page 166 -171 9.
Shanmugam Manoharan, et al, Antihyperglycemic and Antilipid peroxidative
effects of Piper longum (Linn.) dried
fruits in Alloxan Induced Diabetic rat, Journal of Biological sciences
6(1):161-168, 2007. 10.
Akihiro Tojo et al,
Suppressing renal NADPH oxidase to treat diabetic nephropathy, Expert Opinion on Therapeutic Targets ,Volume 11, Issue 8, 2007 11. Rangasamy
Anandan, Preventive Effects of Picrorhiza kurroa on D-Galactosamine-Induced
Hepatitis in Rats, Journal of Clinical Biochemistry and Nutrition ,Vol. 25
(1998) No. 2
P87-95
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