| CTRI Number |
CTRI/2025/09/094102 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparsion between lekhan vasti and mustadi gana vasti in treating Obesity |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Mustadi Gana Vasti (Kala Vasti) versus Lekhana Vasti (Kala Vasti) in the management of Obesity (Sthoulya): A randomized clinical trial |
| 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 ADESH KRUSHNAKANT PANDAV |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Room number 40 Department of Panchakarma Mahatma Gandhi Ayurved College Hospital and research center salod Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8379004814 |
| Fax |
|
| Email |
adeshpandav64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHWETA PARWE |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Room number 40 Department of Panchakarma Mahatma Gandhi Ayurved College Hospital and research center salod Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403142270 |
| Fax |
|
| Email |
shweta.parwe@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ADESH KRUSHNAKANT PANDAV |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Room number 40 Department of Panchakarma Mahatma Gandhi Ayurved College Hospital and research center salod Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8379004814 |
| Fax |
|
| Email |
adeshpandav64@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
| Address |
Room no 40 Department of Panchakarma Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra India 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ADESH PANDAV |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room no 40 , Department of Panchakarma
Wardha
MAHARASHTRA |
8379004814
adeshpandav64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | AsthApana-bastiH/ nirUha-bastiH, आस्थापन-बस्तिः/ निरूह-बस्तिः | (Procedure Reference: CHARAK SIDDHISTHAN 3/69, Procedure details: Subject will be introduced to the medicine as per schedule dose 960ml)
(1) Medicine Name: LEKHANA VASTI, Reference: ASHTANG HRIDAY, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 960(ml), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Procedure | - | AsthApana-bastiH/ nirUha-bastiH, आस्थापन-बस्तिः/ निरूह-बस्तिः | (Procedure Reference: CHARAK SIDDHISTHAN 3/69, Procedure details: Subject will be introduced to the medicine as per schedule dose 960ml)
(1) Medicine Name: MUSTADI GANA VASTI, Reference: SUSHRUT SUTRASTHAN 35/54, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 960(ml), Frequency: od, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients are willing to give written informed consent
2.Patients of either sex aged between 20 and 60 years
3.A patient who is fit for Vasti
4.Primary obesity
5.The patients selected for the clinical trial were selected according to signs and symptoms of Sthoulya described in Ayurvedic texts and modern parameters
6.BMI is between 27 to 40
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from pulmonary disease, Cardiac diseases, Endocrine disorders, and complicated cases were not taken for the study. Patients having a BMI of more than 40 above i.e., class II, III, extremely high obesity and severe complicated cases, will be excluded.
2.Patients with uncontrolled type 2 diabetes.
3.Pregnant and lactating women.
4.Sthoulya with pregnancy and with other significant associated illnesses, patients taking corticosteroids, oral contraceptive pills.
5.Drug-induced obesity (E66.1 of ICD-10 criteria)
6.Obesity due to any secondary causes, i.e, (Endocrine causes: Hypothyroidism, Cushing’s disease), (Genetic causes: Monogenic obesity: Leptin and leptin receptor deficiency), (Syndromic obesity: Prader–Willi syndrome, Bardet-Biedl syndrome)
7.Toxicological contents are excluded from the trial group. (Semecarpus anacardium, Aconitum heterophyllum)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Mustadi Gana Vasti over BMI, Anthropometric measures, and Lipid Profile (Blood Cholesterol level) in patients with obesity. |
16th and 48th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Mustadi Gana Vasti over BMI, Anthropometric measures, and Lipid Profile (Blood Cholesterol level) in patients with obesity. |
16th and 48th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
09/10/2025 |
| 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 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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly
selected as per computer generated table. Clinical research format will be prepared and validated.
Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI
registration will be done. After selection, each participant will be tested individually and
selected according to selection criteria. They are divided into two groups the trial is a Randomized
open labelled Standard controlled superiority clinical trial. It will include a 48 days treatment
period and at Day follow up period baseline, 16th and 48th day. |