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CTRI Number  CTRI/2018/02/012020 [Registered on: 21/02/2018] Trial Registered Retrospectively
Last Modified On: 19/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study On The Effect Of Medicated Enema And Ayurveda Medicine In the Managment Of Sthoulya ( Obesity) 
Scientific Title of Study   A Comparative Clinical Study on Guduchi Bhadramustadi Lekhana Basti and Guduchi Bhadramustadi Ghan vatiin 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 Krishna Gupta 
Designation  PG scholar 
Affiliation  National Institute of Ayurveda 
Address  Department of Panchakarma National Institute of Ayurveda Madhav Vilas Palace Jorawarsingh Gate jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9451316324  
Fax    
Email  cutekrishna.gupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopesh Mangal 
Designation  Assistant Professer 
Affiliation  National Institute Of Ayurveda 
Address  Department of Panchakarma National Institute of Ayurveda Madhav Vilas Palace Jorawarsingh Gate Department of Panchakarma National Institute of ayurveda

Jaipur
RAJASTHAN
302002
India 
Phone  9451316324  
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr krishna gupta 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda 
Address  Department of Panchakarma National Institute of Ayurveda Madhav Vilas Palace Jorawarsingh Gate jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9451316324  
Fax    
Email  cutekrishna.gupta@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda Dept of Panchkarma, rppm no 15,Madhav Vilas Palace Amer Road Jorawarsingh Gate Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Dept OF Panchkarma Nationl Institute of Ayurveda Madhav Vilas Palace JorawarSingh Gate Jaipur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
self krishna gupta   National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jorawarsingh Gate Jaipur 302002 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr krishna gupta  National Institute of Ayurveda  Dept. Of Panchkarma room no 15 Madhav Vilas Palace Amer Road Jorawar singh Gate
Jaipur
RAJASTHAN 
9451316324

cutekrishna.gupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethices committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Diagnosed patients of sthoulya w.s.r. obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  lekhana basti group A  Guduchibhadramustadi Lekhana Basti will be given in Kala Basti manner for 16 days (2Anuvasana+ 1 Niruha + 1 Anuvasana + 1 Niruha + 1 Anuvasana + 1 Niruha + 1 Anuvasana + 1 niruha + 1 anuvasna +1 niruha + 1 anuvasana +1 niruha +1 anuvasana + 1 anuvasana + 1 anuvasana) will be administered alternatively dose 420ml of niruha basti and 60 ml for anuvasan basti.  
Comparator Agent  group B ghana vati  Guduchibhadramustadi Ghan vati will be given in dose of 2 tablet (each of 500mg) twice a day with triphala kwath (40ml) for 16 days  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age between 16-70yrs suffering from Sthoulya irrespective of religion sex occupation etc.
Patients who fulfill the criteria of Sthoulya Patients who are fit for Basti.
BMI> 25kg/m2 To 35kg/m2
 
 
ExclusionCriteria 
Details  Patients below the age of 16 years and above 70years.
Patients with long term steroid treatment.
Patients with uncontrolled hypertension, uncontrolled diabetes mellitus.
Patients with evidence of severe renal, hepatic and cardiac diseases.
Pregnant women and lactating mother.
Patients who have any severe metabolic disorder.
BMI - > 35kg/m2
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement in subjective and objective parameter  3 month 
 
Secondary Outcome  
Outcome  TimePoints 
Overall effect of the treatment in the management of Sthaulya  1 year 6 months 
 
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/ Phase 3 
Date of First Enrollment (India)   08/08/2017 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Obesity is common but often underestimated condition of clinical and public health importance in many countries around the world. Obesity is defined as a condition of abnormal or excessive fat accumulation in adipose tissue,to the extent that health is impaired. In Ayurveda Sthula Purusha (obese person) is considered as one of the Nindita Purusha. Acharya Charaka has explained the Swasth Purusha as Samamamsa, Samapramana, Samasahnana and having DridhaIndriya but Sthoul Purusha is not having such qualities while Sushruta said that Sthula is Sadatura (permanent patient) and need regular and continuous treatment. In Ayurveda Sthoulya is one of the Santarpanoth Vayadi and line of treatment of Santarpamoth Vayadhi  is Aptarpana. In Sthoulya Aptarpana can be done mainly by Sanshodhana particularly Ruksha and Tikshana Basti. Thirty patients (15 patients in each group) suffering with Sthoulya (obesity) fulfilling the inclusion and diagnostic criteria will be selected from O.P.D. and I.P.D. of, N.I.A. Jaipur by simple randomized method. The patients are equally divided and randomized divided into two groups with 15 patients each viz. group A Guduchibhadramustadi lekhana basti and in group B Guduchibhadramustadi Ghana vati . Written consent will be taken from the patient before starting trial. Assessment will be done before treatment, after treatment and during last follow up. Observations and results of the treatments will be compared and statistically tested. Conclusion will be drawn on the basis of observations and finding of statistical analysis.

 
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