| CTRI Number |
CTRI/2017/08/009430 [Registered on: 21/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative clinical Effect of Ayurvedic procedures Lekhana Basti & Rechana Nasya in the management of Obesity |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy Basti & Nasya karma 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 |
DrSriniwas Sharma |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Panchakarma
National Institute of Ayurveda, Jorawar Singh Gate
Jaipur, 302002.
Jaipur
RAJASTHAN
302002
India |
| Phone |
7742555999 |
| Fax |
|
| Email |
vd.sriniwas.nia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Panchakarma
National Institute of Ayurveda, Jorawar Singh Gate
Jaipur, 302002.
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Panchakarma
National Institute of Ayurveda, Jorawar Singh Gate
Jaipur, 302002.
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Amber road, Jorawar Singh Gate, Jaipur,Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda, Amber road Jorawar Singh Gate,Jaipur,Rajasthan,India
Jaipur, 302002.
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sarvesh Kumar Singh |
P.G. Department of Panchakarma
National Institute of Ayurveda, Jorawar Singh 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 Preeti Swami |
National Institute of Ayurveda |
P.G. Department of Panchakarma
National Institute of Ayurveda, Jorawar Singh Gate
Jaipur, 302002.
Jaipur
RAJASTHAN |
8696949352
drpreetigora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of National institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lekhan basti |
Lekhana Basti which was given in Karma Basti manner for 30 days with Anuvasana Basti in the dose of 120 ml and Asthapana Basti in the dose of approximately 960 ml in one group of 15 patient |
| Comparator Agent |
Rechan Nasya |
Rechana Nasya karma on alternate days with dose of 8 drops(approx.5ml) per nostril for total 28 days in another group of 15 patients suffered from Obesity |
|
|
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 Atisthoulya & Obesity.
3.Patients who are fit for Lekhana Basti & Rechana Nasya 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 & Rechana Nasya 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 months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/11/2015 |
| Date of Study Completion (India) |
30/03/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
the results are published Jornal of Ayurveda and Intigrative medicine vol 11 issue 2 April June2020 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study was a randomized open label parallel group trial comparing the efficacy of Ayurvedic Panchakarma procedures such as Lekhan basti (~medicated enema for obesity) which was given in Karma basti manner for 30 days with 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 Triphaladi 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 Rechan nasya karma(~nasal therapy) with Triphaladi taila (oil) on alternate days with dose of 8 drops(approx.5ml) in another group of 15 patients suffered from obesity. The trial was 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.Result obtained in both groups were significant. Lekhan basti group was more effective in this trial. |