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CTRI Number  CTRI/2017/08/009215 [Registered on: 01/08/2017] Trial Registered Prospectively
Last Modified On: 29/07/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study on anal administration of drugs (basti) along with oral medicine in the management of obesity 
Scientific Title of Study   A comparative clinical study of the efficacy of Triphaladi vidangadi lekhan basti and Vidangadi Ghana vati in the management of Sthoulya w.s.r. to obesity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarvesh Kumar Singh 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda Jaipur 
Address  P.G. department of Panchakarma National Institute of Ayurveda,Madhav Vilas Hospital,Jorawar Singh Gate Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8739860237  
Fax    
Email  sarveshksingh21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarvesh Kumar Singh 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda Jaipur 
Address  P.G. department of Panchakarma National Institute of Ayurveda,Madhav Vilas Hospital,Jorawar Singh Gate Jaipur


RAJASTHAN
302002
India 
Phone  8739860237  
Fax    
Email  sarveshksingh21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunil Kushwah 
Designation  M.D. Scholar 
Affiliation  National institute of Ayurveda 
Address  P.G. department of Panchakarma, National Institute of Ayurveda,Jorawar singh Gate Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9462369357  
Fax    
Email  krishayush25@gmail.com  
 
Source of Monetary or Material Support  
National institute of Ayurveda Jaipur 
 
Primary Sponsor  
Name  National Insytitute of Ayurveda 
Address  N.I.A.Jorawar Singh Gate Jaipur 
Type of Sponsor  Research institution and hospital 
 
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 Sarvesh Kumar Singh  National Institute of Ayurveda  Room no.2, Department of Panchakarma,National institute of Ayurveda Jorawar Singh Gate Jaipur
Jaipur
RAJASTHAN 		 8739860237

sarveshksingh21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee National institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Triphala Vidangadi Lekhan bast (medicated enema for obesity)for 15 days  Triphala Vidangadi Lekhan bast (medicated enema for obesity)will be given in Kala basti manner for 15 days in the dose of 920ml for Niruha basti(decoction enema)and 120 ml for Anuvasan enema(oil enema)  
Comparator Agent  Vidangadi Ghan Vati   Vidangadi Ghan Vati in the dose of 500 mg twice in a day with anupana of Triphala Kwath(decoction)in the dose of 40 ml twice in a day 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age Between 16-70 years, suffering from Sthoulya (Obesity) irrespective of religion, sex, occupation etc.
2.Patients who fulfil the criteria for sthoulya & Obesity.
3.Patients who are fit for Lekhana Basti karma.
4.Patient who are not on any other medicine for Sthoulya
  
 
ExclusionCriteria 
Details  1.Patients with long term Steroid treatment.
2.Patients suffering from obesity due to hereditary indisposition.
3.Patients with severe Hypertension.
4.Patients with evidence of Renal, Hepatic and Cardiac involvement.
5.Patients with Diabetes mellitus.
6.Pregnant women, lactating mother.
7.Patients who are unfit for Lekhana Basti karma.
8.Patients who have any severe metabolic disorder.
 
 
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
BMI,
Hip circumference,
Waist circumference,
Mid thigh circumference,
Mid arm circumference.
Skin fold thickness
  

2 months
  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life   2 month 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/09/2017 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized open label parallel group trial comparing the efficacy of Lekhan basti (~medicated enema for obesity) which will be given in Kala basti manner for 15 days of  Anuvasana basti(medicated oily enema) with Triphaladi taila (oil) and Saindhav lavan (rock salt) in the total dose of 120 ml and Asthapana basti with Triphala vidangadi kwath (decoction),Triphaladi oil,honey and Kalka(paste of medicinal drugs) in the total dose of 960 ml in one group of 15 patients and Vidangadi Ghan Vati in another group of 15 patients suffered from obesity. The trial will be conducted in National institute of Ayurveda Jaipur India with primary outcome of reduction in BMI, Hip circumference,waist circumference,mid thigh and mid arm circumference and skin fold thickness.  
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