| CTRI Number |
CTRI/2025/06/088827 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Guduchibhadramustadi Basti and Lekhaniya Basti in Obesity Management |
|
Scientific Title of Study
|
A comparative clinical study on Guduchibhadramustadi Basti and Lekhaniya Basti in the management of Sthkulya w.s.r to 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 |
Dr Nikita Damodhar Wayal |
| Designation |
MD Scholar |
| Affiliation |
YMT Ayurvedic Medical College and Hospital |
| Address |
Panchakarma Department, Dr. G.D. Pol Foundation YMT Ayurvedic
Medical College and Hospital, Institutional Area, Sector 4, Kharghar,
Navi Mumbai
Raigarh
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7030869510 |
| Fax |
|
| Email |
nikitawayal1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Gholap Dhomse |
| Designation |
Hod and Associate professor |
| Affiliation |
Dr.G.D.Pol Foundation YMT Ayurved Medical college |
| Address |
Panchakarma dept.Dr.G.D.Pol foundation,YMT Ayurvedic college
and hospital,institutional area kharghar
Raigarh
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9833971482 |
| Fax |
|
| Email |
kalpu.gholap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Gholap Dhomse |
| Designation |
Hod and Associate professor |
| Affiliation |
Dr.G.D.Pol Foundation YMT Ayurved Medical college |
| Address |
Panchakarma dept.Dr.G.D.Pol foundation,YMT Ayurvedic college
and hospital,institutional area kharghar
Raigarh
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9833971482 |
| Fax |
|
| Email |
kalpu.gholap@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Ayurvedic College and hospital , Kharghar |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Damodhar Wayal |
| Address |
Panchakarma Department, Dr. G.D. Pol Foundation YMT Ayurvedic
Medical College and Hospital, Institutional Area, Sector 4, Kharghar,
Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| 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 Nikita Damodhar Wayal |
Dr. G. D. Pol Foundation YMT Ayurvedic Medical College and Hospital |
First floor Panchakarma Department, Dr. G.D. Pol Foundation YMT Ayurvedic Medical College and Hospital, Institutional Area, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210 Raigarh MAHARASHTRA
Raigarh
MAHARASHTRA |
7030869510
nikitawayal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee YMT Ayurvedic Mahavidyalaya Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z683||Body mass index (BMI) 30-39, adult. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | BASTI | (Procedure Reference: charak sutrastana 21/21-24, Procedure details: Makshika -240gm
Saindhava-10gm
Til Taila-120 ml
Putoyavanyadi Kalka-80gm
Guduchi-Bhadramustadi
Kvatha-480ml
Basti Dravya has been given by anal route by simple rubber catheter attached to plastic
container (basti putak) in left lateral position having right leg flexed towards abdomen &
left leg extended, followed by tadan karma at sphika pradesh)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical signs and 1.symptoms of Sthoulya like Chala Udara, Stana, Sphika , Durbalata , Atikshudha , Atitrishna, Angagaurava
2.Patient with BMI ranging between 25 to 39.9 kg/m² . |
|
| ExclusionCriteria |
| Details |
1.Class 3 obesity BMI more than 40
2.Patients having serious Cardiac, Renal, and Hepatic diseases
3.Patients having major illness like Diabetes Mellitus.
4.Patients having history of untreated thyroid disorders and uncontrolled Hypertension and other endocrine diseases.
5.Pregnant women and lactating mother |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of Guduchibhadramustadi Basti and Lekhaniya Basti on
anthropometric measurements in the management sthoulya. |
Baseline,15th and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to asses the effect of Guduchibhadramustadi Basti in improving BMI and waist circumference |
Baseline,15th and 45th |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/07/2025 |
| 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="2"
Months="0"
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
|
A Comparative Clinical Study on Guduchibhadramustadi Basti and Lekhaniya Basti in the Management of Sthoulya w.s.r to Obesity"
AIMS To evaluate and compare the effectiveness of Guduchibhadramustadi Basti and Lekhaniya Basti in the management of Sthoulya.
0BJECTIVES To compare the effectiveness of Guduchibhadramustadi Basti and Lekhaniya Basti on anthropometric measurements in the management sthoulya.
SAMPLE SIZE - 88
1.Group
Group A-Guduchibhadradi Basti For 15days Group B- Lekhaniya Basti For 15days
2.Follow up on 15 45 day
3.Data collection
4.Statistical analysis of data
5.Final conclusion
Name of Student -Dr Nikita Damodhar Wayal
Name of Guide
|