| CTRI Number |
CTRI/2025/03/082516 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Haritaki churna with Madhu in Sthoulya w.s.r to Obesity |
|
Scientific Title of Study
|
A Clinical Study to evaluate the efficacy of Haritaki churna with Madhu in the management of Sthoulya w.s.r.to Obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Kumar |
| Designation |
MD (Ay) SCHOLAR |
| Affiliation |
Government Ayurvedic College and hospital |
| Address |
Department of Kayachikitsa Government Ayurvedic college and hospital Kadamkuan patna
Patna
BIHAR
800003
India |
| Phone |
7488184218 |
| Fax |
|
| Email |
santoshkumar19988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujeet Kumar |
| Designation |
Associate professor |
| Affiliation |
Government Ayurvedic College and hospital |
| Address |
Department of Kayachikitsa Government Ayurvedic college and hospital Kadamkuan patna Bihar
Department of Kayachikitsa Government Ayurvedic college and hospital Kadamkuan patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
9123272204 |
| Fax |
|
| Email |
drsujitkr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujeet Kumar |
| Designation |
Associate professor |
| Affiliation |
Government Ayurvedic College and hospital |
| Address |
Department of Kayachikitsa Government Ayurvedic college and hospital Kadamkuan patna Bihar
Patna
BIHAR
800003
India |
| Phone |
9123272204 |
| Fax |
|
| Email |
drsujitkr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kayachikitsa, Government Ayurvedic college and hospital Kadamkuan patna 800003 Bihar India |
|
|
Primary Sponsor
|
| Name |
Dr Santosh Kumar |
| Address |
Department of Kayachikitsa Government Ayurvedic college and hospital Kadamkuan patna Bihar 800003 |
| 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 Santosh Kumar |
Government Ayurvedic College and hospital |
Department of Kayachikitsa Government Ayurvedic college and hospital Kadamkuan patna Bihar 800003
Patna
BIHAR |
7488184218
santoshkumar19988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GACH, patna |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki churna , Reference: Charak sutra sthan (23/9), Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 16yrs to 70yrs and irrespective of sex presenting with the classical features of Sthoulya
Patients of raised lipid profile (S.Triglyceride more than 150mg/dl,S.chlolesterol more than 200mg/dl)and BMI more than 30 must be included |
|
| ExclusionCriteria |
| Details |
Patients having age less than 16 and above 70yrs.
Patients with any major illness like chronic liver disease, Heart disease, etc.
Hyperlipidemia due to drugs e.g. glucocorticoids etc.
Pregnant women are excluded in this Study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visceral obesity and pendulous abdomen, pendulous buttock, breathlessness ,oversleeping |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The objective assessment will be done on the basis of changes in clinical finding BMI and relevant laboratory parameters like LIPID PROFILE before and at the end of the trial. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
23/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The study is randomised open interventional prospective trial to study the effect Haritaki churna with Madhu in the management of Sthoulya with special referrence to Obesity in a group of 30 patients.This study will be conducted in Government Ayurvedic College and Hospital ,Patna Bihar in the department of Kayachikitsa. After 15 days of intervention two follow up will be done every 15 days for total durration of study i.e of 45 days. |