| CTRI Number |
CTRI/2021/02/031518 [Registered on: 24/02/2021] Trial Registered Prospectively |
| Last Modified On: |
25/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A STUDY TO COMPARE ROLE OF BHADRADI ASTHAPAN BASTI(MEDICATED ENEMA) WITH LEKHANA BASTI (MEDICATED ENEMA)IN THE MANAGEMENT OF OBESITY |
|
Scientific Title of Study
|
A COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF BHADRADI ASTHAPAN BASTI WITH LEKHANA BASTI IN THE MANAGEMENT OF STHAULYA (OBESITY) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA YADAV |
| Designation |
PG SCHOLAR (DEPARTMENT OF PANCHKARMA) |
| Affiliation |
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
| Address |
DEPARTMENT OF PANCHKARMA,CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN,KHERA DABAR,NAJAFGARH
South West
DELHI
110073
India |
| Phone |
8168039938 |
| Fax |
|
| Email |
yadavneha282200@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR ARUN GUPTA |
| Designation |
HEAD OF DEPARTMENT (PANCHKARMA) |
| Affiliation |
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
| Address |
DEPARTMENT OF PANCHKARMA,CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN,KHERA DABAR,NAJAFGARH
South West
DELHI
110073
India |
| Phone |
9999155377 |
| Fax |
|
| Email |
ARUN24@HOTMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
PROF DR ARUN GUPTA |
| Designation |
HEAD OF DEPARTMENT (PANCHKARMA) |
| Affiliation |
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
| Address |
DEPARTMENT OF PANCHKARMA,CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN,KHERA DABAR,NAJAFGARH
South West
DELHI
110073
India |
| Phone |
9999155377 |
| Fax |
|
| Email |
ARUN24@HOTMAIL.COM |
|
|
Source of Monetary or Material Support
|
| CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR, NAJAFGARH,NEW DELHI 110073 |
|
|
Primary Sponsor
|
| Name |
CBPACS |
| Address |
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR,NAJAFGARH |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| NEHA YADAV |
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
PANCHKARMA THERAPY SECTION ROOM NO.-238,CBPACS,KHERA DABAR
South West
DELHI |
8168039938
yadavneha282200@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: STHAULYA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BHADRADI ASTHAPANA BASTI |
Bhadradi Asthapana Basti for 16 days in the form of KALA BASTI then discontinued for 16 days and given again for next 16 days.
DOSE-450ml |
| Comparator Agent |
LEKHANA BASTI |
Lekhana Basti for 16 days in the form of KALA BASTI then discontinued for 16 days and given again for next 16 days.
DOSE-450ml |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group 20 - 50 years.
2.Patients of either sex – male or female
3.Patients with BMI 25-40 kg/m2
|
|
| ExclusionCriteria |
| Details |
1.Patients of Sthoulya with severe complications like Cerebral vascular diseases, Ischemic heart diseases will be excluded.
2.Patients having any renal, hepatic or cardiac involvement.
3.Pregnant or lactating women.
4.Patient having any malignancy.
5.All those people who are unfit for basti as per Shastra - Pandu, Unmada, Visuchika, Alasaka, Kustha, Hikka, Svasa, Kasa, Bala, Vriddha, Chidrodara, Murchita etc.
|
|
|
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 |
| Required changes in BMI |
16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Required changes in BMI and other features of sthaulya. |
16 DAYS |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/03/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is the open label parallel group trial comparing the effect of Bhadradi asthapana basti with lekhana basti in the management of Sthaulya. In one group Bhadradi asthapana basti will be given to patient for 16 days(Kala basti with murchit Tila oil) and discountinued for 16 day then again given for 16 days in the dose of 450ml. In another group, Lekhana basti will be given to patient for 16 days(Kala basti with murchit Tila oil) and discountinued for 16 day then again given for 16 days in the dose of 450ml. The trial will be conducted in CBPACS with outcome of change in BMI and other features of Sthaulya. |