FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/10/010127 [Registered on: 18/10/2017] Trial Registered Retrospectively
Last Modified On: 14/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of Panchakarma (Vamana) and Varadi Ghanavati in Prameha (Diabetes mellitus)  
Scientific Title of Study   Controlled Evaluation of the Composite Management of Prameha with Samshodhana and Varadi Ghanavati. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailesh Vinayak Deshpande 
Designation  Post Graduate Student 
Affiliation  R A Podar Medical College (Ayu) 
Address  Department of Kayachikitsa,R A Podar Medical College (Ayu), Dr. Anne Besant Road, Worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashikant S Sakapal 
Designation  Lecturer in Kayachikitsa 
Affiliation  R A Podar Medical College (Ayu) 
Address  Department of Kayachikitsa,R A Podar Medical College (Ayu), Dr. Anne Besant Road, Worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  9892439562  
Fax    
Email  drsssakapal@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashikant S Sakapal 
Designation  Lecturer In Kayachikitsa 
Affiliation  R A Podar Medical College (Ayu) 
Address  Department of Kayachikitsa,R A Podar Medical College (Ayu), Dr. Anne Besant Road, Worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  9892439562  
Fax    
Email  drsssakapal@rediffmail.com  
 
Source of Monetary or Material Support  
Dabur Research & Development Centre (DRDC), Plot No. 22, Site-IV, Sahibabad-201 010 Ghaziabad, (UP), India 
 
Primary Sponsor  
Name  The Dean R A Podar Medical College Ayurveda 
Address  Dr. Anne Besant Road, Worli, Mumbai 400018 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashikant S Sakapal  M A Podar Hospital Ayu  OPD No 12 and 13, M A Podar Hospital (Ayu), Dr. Anne Besant Road, Worli, Mumbai 400018
Mumbai
MAHARASHTRA 		 9892439562

drsssakapal@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee RA Podar Medical College Ayu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glibenclamide  Tablet Glibenclamide 5 mg in dose of one tablet twice daily orally with water for three months 
Intervention  Panchakarma (Vamana) treatment followed by Varadi Ghanavati  Panchakarma (Vamana) treatment conducted once, which is followed by Varadi Ghanavati 500 mg in dose of one tablet thrice daily orally with water for three months. 
Intervention  Varadi Ghanavati  Varadi Ghanavati 500 mg in dose of one tablet thrice daily orally with water for three months. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients showing classical symptoms of Prameha, who are either a known diabetic for less than a year or a newly diagnosed diabetic.
2. Fasting blood sugar below 250 mg/dl and post prandial blood sugar below 500 mg/dl.
3. Fit for Vamana treatment
 
 
ExclusionCriteria 
Details  1. Fasting blood sugar above 250 mg% and post prandial blood sugar above 500mg%.
2. IDDM and those who are under insulin therapy.
3. Acute or chronic complications of Diabetes mellitus
4. Suffering from other diseases such as Tuberculosis, cardiac diseases.
5. Unfit for Vamana 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect on symptoms of Prameha according to four point scale at the interval of 2 weeks till 12 weeks.
Effect on Blood sugar - fasting and post prandial at the interval of 2 weeks till 12 weeks. Effect on glycosylated haemoglobin (HbA1c) at base line and 12 weeks. 		 Effect on symptoms of Prameha according to four point scale.
Effect on Blood sugar - fasting and post prandial, glycosylated haemoglobin 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on lipid profile, Haemogram, Renal profile, Hepatic Profile at the base line and at 12 weeks. Effect on weight and body mass index (BMI) at the interval of 2 weeks till 12 weeks  At base line and 12 weeks.
At the interval of 2 weeks till 12 weeks. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   12/08/2004 
Date of Study Completion (India) 17/12/2005 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ayurveda prescribes Shodhana - Panchakarma as the first line of treatment in newly diagnosed obese patients of Prameha (Diabetes Mellitus). Due to the body cleansing effect of Panchakarma it evacuates Dosha responsible for causing Prameha. As it is  disease predominantly caused due to Kapha, Vamana is the treatment of choice as first line of treatment. But effect of Vamana in cases of Prameha (Diabetes mellitus) remains largely unexplored. 

After Shodhana - Panchakarma treatment, use of medicines is the second line of treatment in Prameha (Diabetes mellitus) as prescribed by Ayurvedic treatises. Varadi Ghanavati is a classical Ayurvedic herbal medicine containing - Vatsaka (Holarrhena antidysentrica wall), Triphala (combination of Amalaki - Emblica officinalis, Haritaki - Terminalia chebula Retz, Bibhitaka - Terminalia bellirica Roxb.), Daruharidra (Berberis aristata), Musta (Cyprus rotundus Linn.), Vijaysara (Pterocarpus marsupium Roxb.). All the ingredients of Varadi Ghanavati are potent Pramehagha. They are also researched for their anti diabetic effects. Hence the study was undertaken to evaluate effect of Shodhana (Vamana) and Varadi Ghanavati in comparison with effect of Varadi Ghanavati without Shodhana (Vamana) treatment and active control treatment with glibenclamide.

The results showed that the group receiving Vamana as well as Varadi Ghanavati showed better control on blood sugar as well as lipid levels. Other two groups receiving Varadi Ghanavati without Shodhana and control group showed good glycemic control but showed no significant change in lipid levels. Hence oral Ayurvedic medication followed by Panchakarma (Vamana) can be better treatment option in treatment of Prameha.

 
Close