| CTRI Number |
CTRI/2024/09/074383 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of lekhan basti in Sthoulya with special reference to obesity |
|
Scientific Title of Study
|
Open randomised controlled clinical study to evaluate the efficacy of lekhan basti with charakokta lekhniya gana over triphala kashay in sthoulya w.s.r. to obesity |
| Trial Acronym |
N |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surabhi Jalandar Devmore |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre , Kodoli. , |
| Address |
Yashwant ayurvedic college post graduate training and research center, panchakarma department OPD Kodoli, Tal. Panhala, Dist Kolhapur, state Maharashtra, 416114, India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7498940352 |
| Fax |
|
| Email |
devmoresj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravikumar B patil |
| Designation |
Professor |
| Affiliation |
yashwant ayurvedic college PGT and RC kodoli |
| Address |
Department of Panchakarma, ground floor at Yashwant ayurvedic college PGT and RC kodoli
Tal panhala
Dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822010316 |
| Fax |
|
| Email |
vaidyaravipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surabhi Jalandar Devmore. |
| Designation |
PG Scholar |
| Affiliation |
yashwant ayurvedic college post graduate training and reasarch centre , Kodoli |
| Address |
Yashwant Ayurvedic College Post graduate training and research centre, Panchakarma department OPD, Kodoli, Tal. Panhala, Dist. Kolhapur, State Maharashtra, 416114, India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7498940352 |
| Fax |
|
| Email |
devmoresj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic College and hospital,kodoli , Tal panhala
Dist kolhapur
State Maharashtra 416114
India |
|
|
Primary Sponsor
|
| Name |
Yashwant Ayurvedic College |
| Address |
Kodoli, Tal Panhala, Dist Kolhapur. |
| Type of Sponsor |
Private 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 |
| DrSurabhi Jalandar Devmore |
Yashwant Ayurvedic College Post graduate training and research centre ,Kodoli. |
Panchakarma OPD and IPD Ground floor Panchakarma Department Yashwant Ayurvedic College Post Graduate Training and Research Centre, Kodoli. Tal. Panhala, Dist. Kolhapur 416114
State Maharashtra
Kolhapur
MAHARASHTRA |
07498940352
devmoresj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairman Institutional ethicas commitee Yashwant Ayurvedic College PGT and RC , Kodoli (Kolhapur) |
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 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: charak samhita sutrasthan chapter no 21 shloka no 21, Procedure details: 320 ml triphala kashay lekhan basti for 16 alternate days )
(1) Medicine Name: triphala kashay, Reference: sharangdhar samhita uttarkhand chapter no 6 shloka no 21, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: charak samhita chapter no 21 shloka no 21, Procedure details: 320 ml kashay of charkokta lekhaniya gana dravays lekhan basti for 16 alternate days )
(1) Medicine Name: charakokta lekhaniya gana , Reference: charak samhita sutrasthan chapter no 4 shloka no 9 , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patient fit for basti
patient of BMI 30 - 35 |
|
| ExclusionCriteria |
| Details |
pateint suffering from HTN DM
patient unfit for basti
pregnant and lactating mother |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of Lekhan Basti will be assessed by doing weight and BMI
Both groups will be compared to see if associated symptoms and signs are lessened after any of those intervention ( lekhan basti with Charakokta lekhaniya gana and triphala kashay ) |
After 16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess during follow up that wheather weight & BMI alongwith typical lakshanas of sthoulya have redused or not . wheather which group has better relief |
After 45 days |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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 4 |
|
Date of First Enrollment (India)
|
05/10/2024 |
| 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) |
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
|
Data collection will be made with the help of history taking. it will be done on day 0 and every follow up will be noted in follow up trial likewise. Data collection tool - associated symptoms and case record format. |