| CTRI Number |
CTRI/2025/02/080492 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of lekhan basti and virechana karma in the management of obesity. |
|
Scientific Title of Study
|
Effect of lekhan basti and virechana karma (triphala churna) in the management of sthaulya (obesity) - A comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Gaurav |
| Designation |
Ph.D. Scholar |
| Affiliation |
Shri Santanpal Singh Ayurvedic Medical College and Hospital |
| Address |
Shri Santanpal Singh Ayurvedic Medical College and Hospital, Mirzapur, Shahjahanpur, UP, 242221
Shahjahanpur
UTTAR PRADESH
242221
India |
| Phone |
9451495580 |
| Fax |
|
| Email |
drshubhamgaurav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satya Deo Pandey |
| Designation |
HOD and Professor of Kaya Chikitsa Department in Ayurveda |
| Affiliation |
Department of Kaya Chikitsa in Ayurveda - Desh Bhagat University |
| Address |
Desh Bhagat University, Mandi Gobindgarh, Fatehgarh Sahib
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9872583155 |
| Fax |
|
| Email |
sdkayachikitsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Gaurav |
| Designation |
Ph.D. Scholar |
| Affiliation |
Shri Santanpal Singh Ayurvedic Medical College and Hospital |
| Address |
Shri Santanpal Singh Ayurvedic Medical College and Hospital, Mirzapur, Shahjahanpur, UP, 242221
Shahjahanpur
UTTAR PRADESH
242221
India |
| Phone |
9451495580 |
| Fax |
|
| Email |
drshubhamgaurav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shubham Gaurav, Shri Santanpal Singh Ayurvedic Medical College and Hospital, Mirzapur, Shahjahanpur, UP, 242221 |
|
|
Primary Sponsor
|
| Name |
Shubham Gaurav |
| Address |
Shri Santanpal Singh Ayurvedic Medical College and Hospital, Mirzapur, Shahjahanpur, UP, 242221 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Shubham Gaurav |
Desh Bhagat University |
OPD No-1, Kaya Chikitsa OPD, Dipartment of Ayurveda, Hospital Block, Mandi Gobindgarh, 147301
Fatehgarh Sahib
PUNJAB |
9451495580
drshubhamgaurav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE, Desh Bhagat University, Off to NH-1, Amloh Road, Mandi Gobindgarh, Fatehgarh Sahib, Punjab, 147301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म Pradhan Karma | (Procedure Reference: Ayurvedic classics, Procedure details: Lekhana Basti- Anuvasana Basti
(Dashmoola taila-50ml-single day) & Niruha Basti (Kwatha dravya, Triphala,
Prakshepa dravya, Shilajit, Yavakshara, Kasisa, Tuttha, Hingu, Madhu, Katu taila,
Gomutra).)
(1) Medicine Name: Dashmoola taila, Kwatha dravya, Triphala, Prakshepa dravya, Shilajit, Yavakshara, Kasisa, Tuttha, Hingu, Madhu, Katu taila, Gomutra, Reference: Ayurvedic classics, Route: Urethral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-कर्म Pradhan Karma | (Procedure Reference: Ayurvedic Classics, Procedure details: Virechana Karma by Triphala Churna, 5gm, BD, Orally, 60 Days)
(1) Medicine Name: Triphala Churna, Reference: Ayurvedic Classics, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
BMI in Between 30 to 45 |
|
| ExclusionCriteria |
| Details |
Age less than 20year and more than 50year, BMI less than 30 and more than 45, Other than male and female, Any Chronic Problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is no significant effect of Lekhana Basti and Virechana Karma with Triphala Churna in the Management of Sthaulya (Obesity) |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lekhana Basti & Virechana Karma with Triphala Churna is havingvsignificant effect in the Management of Sthaulya (Obesity) |
60 Days |
The hypothesis behind the study is Lekhana Basti is more effective than Virechana Karma with Triphala Churna in the management of Sthaulya
(obesity) |
60 Days |
The hypothesis behind the study is Virechana Karma with Triphala Churna is more effective than LekhanaBasti in the management of Sthaulya
(obesity) |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
80 patients of the Sthaulya (obese) will be selected from OPD & IPD in SSPS Ayurvedic Medical College and Hospital, Mirzapur, Shahjahanpur, UP, 242221 as well as Desh Bhagat University(Department of Ayurveda), Mandi, Gobindgarh, Fatehgarh Sahib, Punjab, 147301. 80 Patients of who fulfill the inclusion criteria irrespective of economic status, occupation, sex and religion will be divided equally into 2 groups, each group consisting of 40 patients. Obese patients in the age group from 20 years to 50 years with BMI in between 30-45 will be included. Patients of both sex. This is the A Comparative Study. Study Period is 60 Days and Assessment Period Done at interval of 30 day. |