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CTRI Number  CTRI/2018/04/013525 [Registered on: 27/04/2018] Trial Registered Retrospectively
Last Modified On: 11/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Diabetes and Ayurved 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY OF VAMANA KARMA AND CHITRAKADIKWATH IN THE MANAGEMENT OF STHOOL PRAMEHI W.S.R. TO TYPE 2 DIABETES MELLITUS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Niharika Jitendrakumar Prajapati 
Designation  MD (Ayu) SCHOLAR 
Affiliation  Govt. Akhandaanand Ayurved College, Ahmedabad 
Address  41/A,Kailashnagar Becharpura Palapur DI- Banaskantha
Panchkarma Department Room no.11 near Elisebridge Bhadra
Ahmadabad
GUJARAT
385001
India 
Phone  7778994755  
Fax    
Email  drniharikaprajapati15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RAM SHUKLA 
Designation  Lecturer  
Affiliation  GOVT. AKHANDANAND AYURVED COLLEGE,AHMEDABAD 
Address  GOVT. AKHANDANAND AYURVED COLLEGE Panchkarma Department Room no.11 near Elisebridge Bhadra
Panchkarma Department Room no.11 near Elisebridge Bhadra
Ahmadabad
GUJARAT
380001
India 
Phone  9426289960  
Fax    
Email  ramayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Niharika Jitendrakumar Prajapati 
Designation  MD (Ayu) Scholar 
Affiliation  Govt. Akhandaanand Ayurved College, Ahmedabad 
Address  41/A Kailashnagar becharpura Palanpur DI-Banaskantha
Panchkarma Department Room no.11 near Elisebridge Bhadra
Ahmadabad
GUJARAT
385001
India 
Phone  7778994755  
Fax    
Email  drniharikaprajapati15@gmail.com  
 
Source of Monetary or Material Support  
GOVERMENT AKANDANAND AYURVED COLLEGE AHMEDABAD AND MANIBEN AYURVED HOSPITAL AHMEDABAD 
 
Primary Sponsor  
Name  GOVERMENT AKANDANAND AYURVED COLLEGE AHMEDABAD 
Address  GOVERMENT AKANDANAND AYURVED COLLEGE AHMEDABAD,BHADRA,AHMEDABAD,380001 
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 
NIHARIKA JITENDRAKUMAR PRAJAPATI  GOVT AKHANDANAND AYURVED COLLEGE AND HOSPITAL AHMEDABAD AND MANIBEN AYURVED HOSPITAL AHMEDABAD  GOVT AKHANDANAND AYURVED COLLEGE AND HOSPITAL,Panchkarma Department Room no.11 near Elisebridge Bhadr AHMEDABAD 380001
Ahmadabad
GUJARAT 		 7778994755

drniharikaprajapati15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GOVT AKHANDANAND AYURVED COLLEGE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PRAMEHI,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A vaman karma with chitrakadi kwath   nil 
Comparator Agent  Group B CHITRAKADI KWATH  NIL 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient having classical signs and symptoms of the disease according to Ayurveda well as
Modern science.
1 Patients of Prameha having BMI 25 to 35
2 Patient of NIDDM with blood sugar level more then - F.B.S.- 126 mg/dl or P.P.B.S.-180 mg/dl.
3 Age group of 16-60 years.
4 Disease chronicity 10 year.
5 Patient otherwise healthy and fit for Shodhana(Vamana) and Chirakadikwath as per the Ayurvedic text 
 
ExclusionCriteria 
Details  Patients of Prameha having BMI < 25 &>35
1 Patients of Type-1 Diabetes or the patients of Type-2 Diabetes taking Insulin.
2 Patients having complications of Diabetes like Nephropathy, Retinopathy, Diabetic
Foot,Carbuncles etc.
3 Age <16 to > 60 years.
4 Patients having Diabetes in association with other endocrinopathies like Pheochromocytoma,
Acromegaly, Cushing’s syndrome, Hyperthyroidism etc.
5 Patients having drug or chemical induced Type-II Diabetes, like glucocorticoids induced or thyroid
hormone induced etc.
6 Patients with genetic syndromes associated with Type-II Diabetes like Down’s syndrome,
Klinefelter’s Syndrome, and Turner’s syndrome etc.
7 Patients complicated with any cardiovascular diseases, renal diseases, Carcinoma or any other
disease effecting multiple body systems and pregnant women etc. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
All the signs and symptoms of Pramehi will be assigned score depending upone their severity to assess the effect of the drugsat the time of before treatment and after treatment.   After 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/05/2017 
Date of Study Completion (India) 01/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="12" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is rendomised, participiant,blinded,parellel group,active controlled trial to compare the efficasy of chitarakadikwath 40 ml bd with or  without vaman karma with the dutation of 6weeks after vaman karma in 30 patienis of sthool prameha.Which will be conducted in india. 
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