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CTRI Number  CTRI/2014/09/005048 [Registered on: 24/09/2014] Trial Registered Prospectively
Last Modified On: 04/10/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   CLINICAL EVALUATION OF CERTAIN AYURVEDIC MEDICINES IN THE MANAGEMENT OF DIABETES MELLITUS 
Scientific Title of Study   CLINICAL EVALUATION OF GOKSHURADI GUGGULU AND GUDUCHI CHURNA IN THE MANAGEMENT OF TYPE II DIABETES MELLITUS (MADHUMEHA) 
Trial Acronym  CEGGMDM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A D JADHAV  
Designation  Research Officer (Scientist-4) 
Affiliation  National Research Institute of Ayurveda-Siddha Human Resource Development 
Address  National Research Institute of Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior – (M.P.)
Aamkho, Gwalior (M.P.)
Gwalior
MADHYA PRADESH
474009
India 
Phone  08085724449  
Fax  0751-2430317  
Email  adjadhav57@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A D JADHAV  
Designation  Research Officer (Scientist-4) 
Affiliation  National Research Institute of Ayurveda-Siddha Human Resource Development 
Address  National Research Institute of Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior – (M.P.)
Aamkho, Gwalior (M.P.)
Gwalior
MADHYA PRADESH
474009
India 
Phone  08085724449  
Fax  0751-2430317  
Email  adjadhav57@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr A D JADHAV  
Designation  Research Officer (Scientist-4) 
Affiliation  National Research Institute of Ayurveda-Siddha Human Resource Development 
Address  National Research Institute of Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior – (M.P.)
Aamkho, Gwalior (M.P.)
Gwalior
MADHYA PRADESH
474009
India 
Phone  08085724449  
Fax  0751-2430317  
Email  adjadhav57@gmail.com  
 
Source of Monetary or Material Support  
National research Institute of Ayurveda Siddha Human resource Development (NRIASHRD), Amkho, Gwalior-474009, (MP) 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic sciences CCRAS 
Address  61-65 Institutional Area Opposite D Block Janak Puri New Delhi 110058  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
National Research Institute of Ayurveda Siddha Human resource Development  National research Institute of Ayurveda Siddha Human resource Development (NRIASHRD), Amkho, Gwalior-474009, Madhya Pradesh. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr AD JADHAV   National Research Institute of Ayurveda-Siddha Human Resource Development   National Research Institute of Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior – 474 009 (M.P.)
Gwalior
MADHYA PRADESH 		 08085724449
0751-2430317
adjadhav57@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of National Research Institute for Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior (M.P.)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type II diabetes mellitus (Madhumeha),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gokshuradi Guggulu & Guduchi churn  Gokshuradi Guggulu (AFI-I, Page 280, API-II Page 112) Dose: 1g (Two tablets of 500 mg) twice daily Dosage form:Tablet of 500 mg Route of Administration :Oral Time of Administration :Twice daily(to be chewed before swallowing) Anupam :Luke warm water Packing form :A Plastic bottle containing 60 tablets Duration of Therapy:12 weeks Guduchi churn(API-I ,page53-55) Dose:3 gm twice daily Dosage form: Churn Route of Administration: Oral Time of Administration: Twice daily after food Anupam: Luke warm water. Packing form:A Plastic bottle containing 30 sachet of 3 gm. Duration of Therapy:12 weeks  
Comparator Agent  None.  Nil. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Diabetics aged between 30 to 60 years.
2.The freshly diagnosed and naive (those who are not taking any Oral Hypoglycaemic Agent.)
3. Patients who are diagnosed to be Type 2 Diabetics by either having Glycosylated haemoglobin (HbA1c) ≥ 6.5% or BS-F > 126 mg% or BS-PP >200 mg%.
4.Willing to participate.
 
 
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 Type I Diabetes Mellitus or 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.Hypertensive patients (> 140 / 90 mm Hg).
5.Patients with poorly controlled Glycaemic status (HbA1c>8%).
6.Symptomatic patient with clinical evidence of Heart failure.
7.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.
8.Pregnant / Lactating women.
9.Patient on steroids, oral contraceptive pills or estrogens replacement therapy.
10.Alcoholics and/or drug abusers.
11.Patients with evidence of malignancy
12.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
13.H/o hypersensitivity to any of the trial drugs or their ingredients.
14.Patients who have completed participation in any other clinical trial during the past six (06) months
15.Patients with Microvascular and other complications of Diabetes Mellitus.
16..The patients suffering from Brittle Diabetes.
17.Any other condition which the Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Change in Glycosylated haemoglobin (HbA1c%)  At screening and at the end of 12 weeks of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
•Change in Blood sugar Fasting. (10-12 hrs after dinner)
• Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ)
•Change in Blood sugar Post - Prandial (100-120 minutes after breakfast)
•SF-36-Health Survey Score
 		 Blood Sugar (F) and (PP)--At Screening, on 14th day, on 28th day, on 42nd day, on 56th day, on 70th day, on 84th day and on 98th day.
SF-36 and DSQ --At Baseline, on 84th day and on 98th day. 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   01/10/2014 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   After the completion of the recruitment and data collection, the data will be analysed at the CCRAS headquarters and findings published by the Council 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The present clinical trial is being done to scientifically validate the clinical safety and efficacy of a combination of the classical Ayurvedic formulations- Gokshuradi Guggulu and Guduchyadi Churna. The Gokshuradi Guggulu is a polyherbal formulation comprising of Tribulus terrestris, Commiphora wightii, Zingiber officinale, Piper nigrum, Piper longum, Terminalia chebula, Terminalia belerica, Emblica officinalis and Cyperus rotundus whereas, Guduchyadi churna primarily comprises of Tinospora cordifolia.  The effect of this combination on the identified objective as well as subjective parameters along with overall Quality of Life will be evaluated in patients suffering from Type II Diabetes Mellitus.        

 
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