| CTRI Number |
CTRI/2025/03/083224 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of Gomutra Haritaki and Atorvastatin on Weight Loss in people with obesity. |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Gomutra Haritaki Yog and Atorvastatin in the management of Obesity-(Sthoulya) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Krushnaji Mute |
| Designation |
BAMS Intern |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Room No 35 Mahatama Gandhi Ayurved College Hospital And Research Centre. Salod H , Wardha ,Maharashtra , India 442001
Room No 35 Mahatama Gandhi Ayurved College Hospital And Research Centre Salod H , Wardha ,Maharashtra , India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9834288643 |
| Fax |
|
| Email |
mutesakshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Krushnaji Mute |
| Designation |
BAMS Intern |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Room No 35 Mahatama Gandhi Ayurved College Hospital And Research Centre , Wardha ,Maharashtra,India 442001
Room No 35 Mahatama Gandhi Ayurved College Hospital And Research Centre , Wardha ,Maharashrtra , India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9834288643 |
| Fax |
|
| Email |
mutesakshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Parwe |
| Designation |
Professor and HOD department of Panchkarma |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Room No 35 Mahatama Gandhi Ayurved College Hospital And Research Centre Wardha Maharashtra India 442001
Room No 35 Mahatama Gandhi Ayurved College Hospital And Research Centre Wardha Maharashtra India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9511659185 |
| Fax |
|
| Email |
shweta.parwe@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre ,Salod Hirapur Wardha 442001 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
| Address |
Room no 35 Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
| 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 |
| Sakshi Mute |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room No 35 Mahatama Gandhi Ayurved College Hospital And Research Centre Wardha ,Maharashtra ,India
Wardha
MAHARASHTRA |
9834288643
mutesakshi@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: MEDOJA-VRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tablet Atrovastatin | Tab Atrovastatin will be adminstered 10 mg OD for 2 months in the morning . | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gomutra Haritaki , Reference: -, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: Gomutra HAritaki will be administered twice a day for 2 months in 15 patients |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient of obesity will be recruited as per ICD Criteria for Obesity Subjects willing to participate in the study and sign the written informed consent Subjects between age group of 20 to 40 years of either sex Subjects having BMI more than or equal to 30 to 40 kg per m2
|
|
| ExclusionCriteria |
| Details |
Known case of Hypothyroidism Diabetes mellitus Cardiovascular Renal Disorder and Drug induced Obesity etc
Pregnant lady and Lactating mother
Any other illness developed during treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To asses the Efficacy of Gomutra Haritaki Yog and Atorvastatin over Weight BMI weight in kg per height in metre square Hip Waist ratio Lipid Profile
|
At 0 days ,15 days , 1 month, 2 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison and assesment of Efficacy of Gomutra Haritaki Yog and Atorvastatin in Weight BMI weight in kg per height in metre square Hip Waist ratio Lipid Profile
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/04/2025 |
| 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="0"
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
|
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 two arm parallel
group, randomized, single blind clinical, standard controlled trial. it will include a 2 months treatment
period and at 15th day , 1month ,2 month follow up period |