| CTRI Number |
CTRI/2012/05/002646 [Registered on: 11/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
01/05/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulations in the management of High Blood Sugar. |
|
Scientific Title of Study
|
Clinical Evaluation of Saptavimshatika Guggulu and Haridra Churna in the Management of Type II Diabetes Mellitus. |
| Trial Acronym |
ACT- DM-2010 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
Central Council for Research in Ayurvedic Sciences (CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
Central Council for Research in Ayurvedic Sciences (CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
Central Council for Research in Ayurvedic Sciences (CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Support in terms of infrastructural facilities:
1. Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar.
2. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Udupi.
3. Government Ayurveda College, Thiruvananthapuram. |
|
|
Primary Sponsor
|
| Name |
Department of AYUSH Ministry of Health Family Welfare Government of India |
| Address |
Department of AYUSH, Ministry of Health & Family Welfare,
Government of India, IRCS Building, Red Cross Road, New
Delhi-110001. |
| 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 |
| Dr N Subhash Babu Dr Sunil John |
Government Ayurveda College, Thiruvananthapuram |
Department of Kayachikitsa, Thiruvananthapuram-695001
Thiruvananthapuram
KERALA |
9447180030
0471-2473656
drnsubhashbabu@gmail.com |
| Dr D H Pandya Dr Nirmal Alodariya |
Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar |
Department of Roga Nidana & Vikriti Vijnana, Gujarat Ayurved University,Jamnagar-361001
Jamnagar
GUJARAT |
9099011095
288-2676856
darshnapandya@rediffmail.com |
| Dr U N Prasad DrPrashasth MJ |
Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Udupi |
Department of Kayachikitsa, P.O. – Kuthpady, Laxminarayana Nagara, Udupi-574118
Udupi
KARNATAKA |
9448252235
0820-2533970
prasadun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. Ayurveda College, Thiruvananthapuram, Kerala, India |
Approved |
| Institutional Ethics Committee, IPGT&RA, Jamnagar, Gujarat, India |
Approved |
| Institutional Ethics Committee, SDM College of Ayurveda, Udupi, Karnataka, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type II Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Saptavimshatika Guggulu Along with Haridra Churna |
SAPTAVIMSHATIKA GUGGULU-Dose – 1gm (2 Tablets) twice daily;
Dosage form - Tablet of 500 mg; Route of Administration – oral;Time of Administration-Twice a day after food;
Anupana-Lukewarm Water;
Packing form- Bottle containg 60 tablets;Duration of therapy-12 weeks And HARIDRA CHURNA-Dose – 3 gm twice daily; Dosage form – Sachet of 3 gm each; Route of Administration – Oral; Time of Administration-Twice a day after food; Anupana-Lukewarm Water; Packing form-Plastic jar containing 30 sachets; Duration of therapy-12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged between 30 to 65 years
2. Treatment naive patients or diagnosed patients of Type II Diabetes Mellitus taking oral hypoglycemic drugs for ≤ 6 weeks
3. Patients having Glycosylated haemoglobin (HbA1c) ≥ 6.5%.
4. Willing and able to participate for 16 weeks |
|
| ExclusionCriteria |
| Details |
1. Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.
2. Patients suffering from brittle diabetes mellitus.
3. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
4. Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg)
5. Symptomatic patient with clinical evidence of Heart failure.
6. 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.
7. Pregnant / Lactating women.
8. Patient on steroids, oral contraceptive pills or estrogen replacement therapy.
9. Alcoholics and/or drug abusers.
10. Patients with evidence of malignancy
11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
12. H/o hypersensitivity to any of the trial drugs or their ingredients.
13. Patients who have completed participation in any other clinical trial during the past six (06) months.
14. Any other condition which the P.I. 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%) |
At Baseline, on 42nd day and on 84th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ)
• Change in Blood sugar Fasting. (10-12 hrs after dinner)
• Change in Blood sugar Post -Prandial. (100-120 minutes after breakfast)
• Change in the SF-36-Health Survey Score. |
At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.
SF-36 done at Baseline, at 84th day and at the end of follow up after 16 weeks. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/01/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
To be published after the completion of clinical trials in all the three centers. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country. Saptavimshatika Guggulu is a poly herbal preparation containing Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), kustha (Saussurea lappa), Vidanga (Embelia ribes), Guduci (Tinospora cordifolia), Citraka (Plumbago zeylanica), Sati (Hedychium spicatum), Sukshma ela (Elettaria cardamomum), Pippali mula (Piper longum), Hapusa (Juniperus communis), Devdaru (Cedrus deodara), Tejovati (Zanthoxylum aromaticum), Puskara (Saussurea lappa), Cavya (Piper chaba), Rakta indravaruni (Citrullus colocynthis), Haridra (Curcuma longa), Daruharidra (Berberis aristata), Vid lavana, Saurvanchala lavana, Saindhava lavana, Yava kshara, Sarji kshara, Gaja pippali (Scindapsus officinalis) and Guggulu (Commiphora wightii). Haridra Churna is prepared by air drying the rhizomes of Haldi (Curcuma longa).The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who are doing the clinical trials to scientifically study and validate the clinical efficacy and safety of Saptavimshatika Guggulu and Haridra Churna- the classical Ayurvedic formulation which have been in use since ages and found to be useful in treating Type II Diabetes Mellitus and promoting the health. The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project. |