| CTRI Number |
CTRI/2025/03/081999 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Treatment for Sthaulya (obesity) by Panchakarma (Basti and Virechana) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the role of Lekhana basti and Virechana karma in Sthaulya (obesity). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jolly Gautam |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital ,Karol Bagh New Delhi |
| Address |
Department of panchakarma Ayurvedic and Unani Tibbia college and hospital ,Karol Bagh Ajmal khan Road ,New Delhi 110005
Central
DELHI
110005
India |
| Phone |
9716066262 |
| Fax |
|
| Email |
jollygautam6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj K Shamkuwar |
| Designation |
Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital ,Karol Bagh New Delhi |
| Address |
Department of panchakarma Ayurvedic and Unani Tibbia college and hospital ,Karol Bagh Ajmal khan Road ,New Delhi 110005
Central
DELHI
110005
India |
| Phone |
9354925019 |
| Fax |
|
| Email |
manojshamkuwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jolly Gautam |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital ,Karol Bagh New Delhi |
| Address |
Ayurvedic and Unani Tibbia college and hospital , Panchakarma OPD no 2,department of panchakarma, Karol Bagh Ajmal khan Road ,New Delhi 110005
Central
DELHI
110005
India |
| Phone |
9716066262 |
| Fax |
|
| Email |
jollygautam6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Department of Panchakarma Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ajmal Khan road ,Block 56 Karol Bagh New Delhi 110005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrJolly Gautam |
Ayurvedic and Unani Tibbia College and Hospital |
OPD NO 2,Department of panchakrma,Ajmal Khan Road Block 56 ,Karol Bagh New Delhi 110005
Central
DELHI |
9716066262
jollygautam6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibiia College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: charaka sutra chapter 23 shloka 8, Procedure details: Deepana Pachana will be done using chitrakadi vati upto nirama lakshanas followed by Snehapana using Goghrita till samyaka snigdha lakshanas. Thereafter Sarvanga abhyanga using Tila taila & Sarvanga bashpa swedana will be done. Virechana karma will then be performed using Trivritta avleha & Triphala kwath followed by Samsarjana krama according to shuddhi.)
| | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: sushruta chikitsa chapter 38 shloka 82, Procedure details: Initiall 190 ml Madhu Honey will be mixed uniformly with 12gm of Saindhava rock salt with the help of Mortar & Pestle. Followed by 300ml of sneha & after that Kalka 90gm will be added & mixed well to ensure a homogeneous texture. To this mixture kashaya 400ml will be added to the mixture & mixed well with a pestle & then add aavapa dravya gomutra 80 ml yavashara & ushkadi gana dravya 90gm & mixed well with the help of a pestle. The mixture will then be filtered through a fine sieve before being kept over a hot water bath to be lukewarm. Anuvasana basti will be given by Triphaladi taila & Niruha basti will be given by Lekhana basti as prescribed in classical text in the sequence of kaala basti.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
pateints with BMI more than or equal to 25 and less than 40 |
|
| ExclusionCriteria |
| Details |
The patient having B.M.I. more than 40 kg/m2
FOR GROUP A Patients contraindicated for Basti karma like, Udara rog, intestinal perforation, intestinal obstruction, Pregnant and lactating women.
FOR GROUP B Patients contraindicated for virechana karma like Rectal prolapse, lower GI bleeding, Incontinence of stool.
Patients with renal (Sr. creatinine more than 1.8mg/dl and Sr. Urea more than 60 mg/dl,) or hepatic impairment (SGOT and SGPT more than Five times of upper limit)
Patients with Blood pressure in the range of more than or equal to 160/100mm of Hg) or more, Diabetes Mellitus (having HbA1c more than 7 % with or without hyperglycemic medications.
Known case of IHD, CAD, CHF or other major cardiovascular problems will not be included for this study.
Patients on anti-tubercular, anti-retroviral, antibiotic medications.
Patients requiring emergency treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of patients showing reduction in BMI, Girth measurements and Skin folds thickness of post lekhana Basti karma and Virechan karma.
|
Day 0 (group A and B)- subjective and objective parameters will be assessed. Vitals examination, CBC, HbA1c, LFT, KFT and Lipid Profile will be done.
In Group A after lekhana basti and In Group B after virechana Vitals examination, Subjective and Objective Parameters will be assessed.
On Day 30th - (group A & B) Vitals examination, Subjective and Objective Parameters will be assessed. CBC, HbA1c, LFT, KFT and Lipid Profile will be done.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The proportion of patients showing changes in the serum leptin post lekhana Basti karma & Virechan karma.
The proportion of patients showing changes in the gut microbiome post lekhana Basti karma & Virechan karma.
|
Day 0 ( both group A & B ) serum leptin ,
gut microbiome for 10 pateints
After lekhana basti & virechana Day 16th gut microbiome (5 pateints) for group A
After 1st day of virechana gut microbiome (5 pateints) for group B
Day 30th both group A & B serum leptin
|
|
|
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)
|
20/03/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As
a lifestyle disease, obesity is among the most prevalent and undertreated
disorders in both industrialized and developing nations, according to the World
Health Organization,Since obesity is a major risk factor for non-communicable
diseases such diabetes mellitus, ischemic heart disease, and cardiovascular
disorders, it is typically linked to increased rates of mortality and morbidity
The
peptide hormone leptin regulates food intake, body mass, and reproductive
function and plays a role in fetal growth, proinflammatory immune responses,
angiogenesis and lipolysis Leptin resistance is characterized by reduced
satiety, overconsumption of nutrients, and increased total body mass. Often
this leads to obesity Ayurvedic classics have mentioned Lekhana Basti and
Virechana Karma among the Shodhana Chikitsa for Sthaulya. The goal of the
current study is to assess the effect of lekhana basti and virechana karma on
biomarker serum leptin and gut microbiota ,BMI and hip waist ration . |