| CTRI Number |
CTRI/2026/03/106017 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effects of Two Herbal Remedies on Reducing Liver Fat in Adults with Fatty Liver Disease |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Evaluate the Effect of Vidangadi Churna in Comparison with Pippalyadi Churna in Reducing Liver Fat Accumulation in Adults with Non Alcoholic Fatty Liver Disease (NAFLD) |
| 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 Kavita Rambhau Bhagat |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Hanuman Nagar, Nagpur 440024 Maharashtra India |
| Address |
Kayachikitsa Department Pakwasa Samanvay Rugnalaya
Shri Ayurved Mahavidyalaya
Hanuman Nagar Nagpur 440024 Maharashtra
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9423018358 |
| Fax |
|
| Email |
bhagatkavitar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Archana Dachewar |
| Designation |
HOD and Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya |
| Address |
Kayachikitsa Department Pakwasa Samanvay Rugnalaya
Shri Ayurved Mahavidyalaya
Hanuman Nagar Nagpur 440024 Maharashtra
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822206312 |
| Fax |
|
| Email |
dr.dachewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Archana Dachewar |
| Designation |
HOD and Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya |
| Address |
Kayachikitsa Department Pakwasa Samanvay Rugnalaya
Shri Ayurved Mahavidyalaya
Hanuman Nagar Nagpur 440024 Maharashtra
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822206312 |
| Fax |
|
| Email |
dr.dachewar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved Mahavidyalaya, Nagpur Maharashtra India-440024 |
|
|
Primary Sponsor
|
| Name |
Dr Kavita Rambhau Bhagat |
| Address |
Kayachikitsa Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur 440024 Maharashtra India |
| 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 Kavita Rambhau Bhagat |
Shri Ayurved Mahavidyalaya, Nagpur |
Kayachikitsa Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Nagpur
MAHARASHTRA
INDIA-440024
Nagpur
MAHARASHTRA |
9423018358
bhagatkavitar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Shri Ayurved Mahavidyalya ,Nagpur |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi, Reference: Yogratnakar-Uttarardha-1/111, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Koshna Dudgha), Additional Information: composition-Vidang,Yavani,Chitrak,Devadaru,Shunti,Punarnava,Trivrit | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi , Reference: Charak Samhita: Ch Chi 13/35,36 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: Composition-Pippali, Shunti, Dantimoola, Chitrakmoola, Vidanga,Haritaki |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 25 and 60 years, irrespective of sex, occupation, or economic status.
2.Radiological evidence of fatty infiltration of the liver confirmed by abdominal Ultrasonography (USG) or other imaging modalities such as Contrast-Enhanced Computed Tomography (CECT).
3.Presence of clinical signs and symptoms suggestive of NAFLD (Yakrut Roga) such as loss of appetite, pain in the right upper quadrant or epigastric region, and nausea. |
|
| ExclusionCriteria |
| Details |
1.Patients with alcohol intake exceeding 20 mL per day (history of alcohol intake was taken separately from the patients and close relatives)
2.Patients with positive diagnostic markers for other liver diseases such as Viral Hepatitis, Autoimmune Hepatitis, Wilson’s Disease, Hemochromatosis.
3.Patients currently dependent on steroids or analgesic medications, or those who have participated in any other clinical trial within the last 6 months.
4.Patients who have undergone major surgery within 2 weeks prior to the screening visit.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in hepatic fat accumulation as measured by ultrasonographic grading before and after the 90-day intervention in adults with Non-Alcoholic Fatty Liver Disease (NAFLD). |
The follow-up time points are on the 30th, 60th, and 90th days of the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
23/03/2026 |
| 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="1"
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
|
This
study involves 54 participants randomized into two equal groups (n=27
each) to compare the efficacy of two formulations over a 90-day period. Group
A: Receives Vidangadi Churna twice daily, administered orally
with lukewarm milk after meals. Group B: Receives Pippalyadi
Churna twice daily, administered orally with lukewarm water after
meals. Clinical assessments will be conducted at 30, 60, and 90 days to
evaluate progress. Final results will be determined based on predefined assessment
criteria.
|