| CTRI Number |
CTRI/2025/04/084560 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An open clinical trial to test the effect of Chirayata [Swertia purpurascens Wall]in the management of Non-Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
An open randomized clinical trial to evaluate the effect of Chirayata [Swertia purpurascens Wall]in the management of Non-Alcoholic Fatty Liver Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Vijay Chaudhary |
| Designation |
Principal cum Dean |
| Affiliation |
|
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra(H.P)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manik Soni |
| Designation |
Senior Lecturer |
| Affiliation |
|
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra(H.P)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816842425 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archna Kumari |
| Designation |
MD Scholar |
| Affiliation |
|
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra(H.P)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018817298 |
| Fax |
|
| Email |
rawatarchu874@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prof Dr Vijay Chaudhary |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra(H.P) |
| Type of Sponsor |
Government medical college |
|
|
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 ARCHNA RAWAT |
Rajiv Gandhi Govt.Post Graduate Ayurvedic college and Hospital Paprola(HP) |
Room no -317 Hospital Building Rajiv Gandhi Govt.Post Graduate Ayurvedic college and Hospital Paprola(HP)
Kangra
HIMACHAL PRADESH |
7018817298
rawatarchu874@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chirayata , Reference: Charak chikitsa 15/137-140, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having altered serum liver enzymes levels defined as serum AST and ALT more than normal but less than 2 times upper normal limit and ultrasonographical evidence of Non -Alcoholic Fatty Liver Disease. |
|
| ExclusionCriteria |
| Details |
Patients having serum liver level enzymes (AST and ALT)levels more than 2 times of upper normal limit .
Patients having hepatitis B and C ,liver malignancy or having any other comorbidity.
Patients consuming alcohol . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To lower the altered serum liver enzyme levels AST AND ALT. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical safety of Chirayata [Swertia purpurascens Wall]in the patients of Non-Alcoholic Fatty Liver Disease |
12 weeks |
|
|
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 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="3"
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
|
At the end of trial collected data will be analyzed by using appropriate statistical methods. |