| CTRI Number |
CTRI/2026/01/100266 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the effect of Yamanikadi Choornam and Agnimanth Kwatha with Shilajatu in the management of Non-alcoholic fatty liver disease(Yakritodara). |
|
Scientific Title of Study
|
A comparative clinical study of Yamanikadi Choornam and Agnimanth Kwatha with Shilajatu in the management of Non-alcoholic fatty liver disease (Grade-I and Grade-II) w.s.r to Yakritodara-An Open Labelled Randomized Study. |
| 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 Vaibhav Khandare |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh,New Delhi 110005 |
| Address |
Ayurvedic and Unani Tibbia College and Hospital,PG Department of Kayachikitsa ,Karol Bagh,New Delhi 110005
Central
DELHI
110005
India |
| Phone |
8308097096 |
| Fax |
|
| Email |
khandarevaibhav982216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh,New Delhi 110005 |
| Address |
Ayurvedic and Unani Tibbia College and Hospital,PG Department of Kayachikitsa ,Karol Bagh,New Delhi 110005
Central
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh,New Delhi 110005 |
| Address |
Ayurvedic and Unani Tibbia College and Hospital,PG Department of Kayachikitsa ,Karol Bagh,New Delhi 110005
Central
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh,New Delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh,New Delhi 110005 |
| 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 |
| Dr Vaibhav Khandare |
Ayurveda and Unani Tibbia College and Hospital |
OPD no. 3, Department of Kayachikitsa
Central
DELHI |
8308097096
khandarevaibhav982216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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: Yamanikadi Choornam, Reference: Bhaishajya ratnavali Plihayakridroga chikitsa 41/9, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -(2) Medicine Name: Agnimantha Kwatha with Shilajatu , Reference: Bhaishajya Ratnavali Medoroga Chikitsa 39/12, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -Shilajatu 250mg is added as prakshepa in kwatha |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 20 to 60 Year (irrespective of gender, religion, economic status and race).
2.Patients with grade I and grade II Non-alcoholic fatty liver disease as per USG findings.
|
|
| ExclusionCriteria |
| Details |
1.Patients having History of uncontrolled HTN (more than160/100mmHg), DM type 1 and type 2.
2.BMI above 39.9 kg per m2
3.Diagnosed cases of alcoholic fatty liver disease, Hepatitis B and C, Cirrhosis of Liver.
Pregnant and lactating women.
4.Patients with any communicable disease like TB, HIV etc. and diagnosed cases of comorbidities.
5.Any other clinical condition which may compromise the safety of the individual study participant.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the Ultrasonography (USG) findings. |
At initial visit and after completion of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of trial drugs on Liver function tests Parameters and Lipid profile. |
At initial visit and after completion of study. |
To assess the changes in the clinical features of Non-alcoholic fatty liver disease (Grade-I and Grade-II) w.s.r to Yakritodara
|
At initial visit and after completion of study. |
| Change in the score of Chronic Liver Disease Questionnarie (CLDQ-NASH Instrument). |
At initial visit, mid of the study(day 45) and after completion of study. |
| Incidence of adverse events |
During the study |
| Change in laboratory safety parameters (CBC, LFT, KFT) |
At initial visit and after completion of study. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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
|
Although classical Ayurvedic texts do not explicitly mention Non-alcoholic fatty liver disease, its clinical presentation aligns with conditions like Medodusti or Medoroga, classified under Santarpanajanya Vyadhi—disorders arising from over-nourishment. In Ayurveda, when fatty infiltration leads to liver enlargement, it is described as Yakritodara—one of the eight types of Udara Roga. Thus, Fatty Liver Disease may be interpreted as an early manifestation of Yakritodara, characterized by excessive Meda deposition in the liver, eventually progressing to full-blown Yakritodara. |