| CTRI Number |
CTRI/2025/06/088986 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of rohitaka-haritaki churna and guduchyadi churna in yakritodara (fatty liver disease) |
|
Scientific Title of Study
|
Randomised comparative clinical study to evaluate the efficacy of rohitaka-haritaki churna and guduchyadi churna in the management of yakritodara with special reference to 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 |
Mamta sirvi |
| Designation |
PG Scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya
Government Ayurved College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005663181 |
| Fax |
|
| Email |
mamtasirvi571@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta sirvi |
| Designation |
PG Scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya
Government Ayurved College Udaipur
RAJASTHAN
313001
India |
| Phone |
8005663181 |
| Fax |
|
| Email |
mamtasirvi571@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta sirvi |
| Designation |
PG Scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya
Government Ayurved College Udaipur
RAJASTHAN
313001
India |
| Phone |
8005663181 |
| Fax |
|
| Email |
mamtasirvi571@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan mohan malviya government ayurved college udaipur rajasthan pin 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan Pin 313001 |
| 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 ravi sharma |
Madan Mohan Malviya Government Ayurved College Udaipur |
OPD No.1 Kayachikitsa Department Madan Mohan Malviya Government Ayurved College Udaipur
Udaipur
RAJASTHAN |
9414419259
Suspencetoday@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMM Govt Ayurved College Ambamata Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi Churna, Reference: Bhaishajya Ratnavali Written By Ambikadatta Shastri Chapter No. 41 Shloka No. 12-14, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NIL | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rohitaka-Haritaki Churna, Reference: Chakradatta Samhita 38th Chapter 13th Shloka, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
CRITERIA OF INCLUSION
1.Age group between 18 to 70 years of either sex.
2.Sonologically diagnosed cases of fatty liver.
3.Patients who agree for the trial and fill the consent form. |
|
| ExclusionCriteria |
| Details |
CRITERIA OF EXCLUSION
1.Patients below the age of 18 years and above 70 years..
2.Grade 4 fatty liver.
3.Pregnant and lactating females.
4.Life threatening conditions [e.g. liver carcinoma]
5.Patients having portal hypertension.
6.Patients having ascites and liver cirrhosis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| USG whole abdomen, LFT (SGOT, SGPT), BMI, LIPID PROFILE (Serum Cholesterol, Serum Triglyceride), FBS will be analysed. |
60 days |
|
|
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 |
|
Date of First Enrollment (India)
|
03/07/2025 |
| 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="0"
Months="11"
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
|
RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ROHITAKA-HARITAKI CHURNA AND GUDUCHYADI CHURNA IN THE MANAGEMENT OF YAKRITODARA W.S.R. TO FATTY LIVER DISEASE
There will be two group in the study.
In Group A randomly selected and clinically diagnosed 30 patient of Yakritodara will be given Rohitaka-haritaki churna twice a day after meal.
In Group B randomly selected and clinically diagnosed 30 patient of Yakritodara will be given Guduchyadi churna twice a day after meal.
Both trial will be conduct for a period of 2 months.
Follow up of the case will be after 15 days that is four time during treatment.
Final assesment will be done after completion of two month course on the basis of subjective and laborateral assesment. |