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
|
|
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. |