CTRI

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CTRI Number

CTRI/2026/04/108577 [Registered on: 17/04/2026] Trial Registered Prospectively

Last Modified On:

16/04/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Effect of Kalmegh and Amalaki on cases of Fatty Liver Disease

Scientific Title of Study

Integrated Management of Metabolic Dysfunction Associated Steatotic Liver Disease Incorporating Traditional Medicine: A Randomized Controlled Trial

Trial Acronym

MASLD

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Sunil Kumar
Designation	Associate Professor
Affiliation	Institute of Medical Science
Address	Department of Community Medicine Institute of Medical Science, Banaras Hindu University, Varanasi Department of Community Medicine Institute of Medical Science, Banaras Hindu University, Varanasi 221005 23,FF, old Medical Enclave(Ved Vyas Colony) BHU Varansi 221005 Varanasi UTTAR PRADESH 221005 India
Phone	9450808948
Fax
Email	sunilk.cmed@bhu.ac.in

Details of Contact Person
Scientific Query

Name	Dr Nitish Suryavanshi
Designation	Junior Resident
Affiliation	Institute of Medical Science
Address	Department of Community Medicine Institute of Medical Science, Banaras Hindu University, Varanasi 23,FF, Old Medical Enclave(Ved Vyas Colony) BHU Varansi 221005 Varanasi UTTAR PRADESH 221005 India
Phone	6265247572
Fax
Email	drnitish1898@bhu.ac.in

Details of Contact Person
Public Query

Name	Dr Sunil Kumar
Designation	Associate Professor
Affiliation	Institute of Medical Science
Address	Department of Community Medicine Institute of Medical Science, Banaras Hindu University, Varanasi Department of Community Medicine Institute of Medical Science, Banaras Hindu University, Varanasi 221005 23,FF, old Medical Enclave(Ved Vyas Colony) BHU Varansi 221005 Varanasi UTTAR PRADESH 221005 India
Phone	9450808948
Fax
Email	sunilk.cmed@bhu.ac.in

Source of Monetary or Material Support

Institute of medical science Bnaras Hindu University

Primary Sponsor

Name	Sponsored Research Industrial Consultancy Cell SRICC for IoE from UGC Ministry of Education
Address	SRICC, Banaras Hindu University, Varanasi - 221005
Type of Sponsor	Other [Professional Development Fund (PDF)]

Details of Secondary Sponsor

Name	Address
nil	nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sunil Kumar	Sir Sunderlal Hospital, IMS, BHU.	OPD of Dept of Gastroenterology, SS Hospital, BHU, Varanasi - 221005 Varanasi UTTAR PRADESH	9450808948 sunilk.cmed@bhu.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:K760\|\|Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: MEDOROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Kalmegh, Reference: Bhavaprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - (2) Medicine Name: Amalaki, Reference: Bhavaprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: water), Additional Information: -
2	Comparator Arm (Non Ayurveda)		-	VITAMINE E , SEROGLITAZAR AND LIFESTYLE MODIFICATIONS	Standard medical therapy like VITAMINE E , SEROGLITAZAR AND LIFESTYLE MODIFICATIONS. Also if patient have diabeties then METFORMINE may be added. Also if patient have hypertension AMLODIPINE may be added. In Lifestlye modification regular excercise, yoga and diet mofification can be recommended.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	59.00 Year(s)
Gender	Both
Details	Patient giving consent to participate in the study. Patient of age between 18-59 years. Patient attending the OPD of SS HOSPITAL, IMS, BHU Varanasi. Patients diagnosed with simple fatty liver based on imaging assessment. Patients diagnosed with MASH or MASH with fibrosis of stage 1, stage 2 and stage 3.

ExclusionCriteria

Details

Patient with significant levels of alcohol consumption.
Patients with liver cirrhosis.
Patients with any other chronic severe illness.
Patients on treatment with other ayurvedic regimens.
Patients not giving consent to participate in the study

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pharmacy-controlled Randomization

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
To assess the effectiveness of Ayurvedic Remedies (Kalmegh and Amalaki) combined with lifestyle interventions on reversal of NAFLD, measured through USG based hepatic steatosis grading, Liver function tests and Fibro scan	Participants will be followed up at 2, 4 and 6 months. (Therapy :4 months, no therapy:2 months (to confirm relapse, if any). This will include LFT, CBC, KFT, Lipid profile, RBS, USG and Fibro scan.

Secondary Outcome

Outcome	TimePoints
To assess the effectiveness of Ayurvedic Remedies (Kalmegh & Amalaki) combined with lifestyle interventions on reversal of NAFLD, measured through USG based hepatic steatosis grading, Liver function tests & Fibro scan	Participants will be followed up at 2, 4 & 6 months. -Therapy: Upto 4 months. -After 4 months, For 2 months (between 4 to 6 months of follow up period) No Therapy: (to confirm relapse, if any). Outcome Investigation at 0, 2, 4 & 6 months will include LFT, CBC, KFT, Lipid profile, RBS, USG & Fibro scan.

Target Sample Size

Total Sample Size="82"
Sample Size from India="82"
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)

11/05/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

11/05/2026

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
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

Participant Recruitment- MASLD cases will be enrolled with documented diagnosis of MASLD from gastroenterology OPD of Sir Sunderlal Hospital, IMS BHU Varanasi. Patient will be scrutinized to make sure that they meet all the inclusion criteria and none of the exclusion criteria.

Written and informed consent will be taken from the patients, explaining about purpose of the study, details of treatment involved, potential risks and benefits, confidentiality, and the right to withdraw anytime without penalty.

These patients will undergo (if not already done), various blood investigations such as:

1.CBC

2.LFT

3.RFT

4.RBS

5.Lipid Profile

6.USG & Fibro scan

Randomization:Included patients will be allocated randomly through computer generated randomisation schedule in group A and group B.

Group A: Intervention group Ayurvedic Regimen i.e Kalmegh 2gm in two divided dose and Amalaki (amla) 2gm in two divided will be given, along with this standard treatment and life style and diet modification will be given.

Group B: Control Group (Standard treatment therapy+ Lifestyle Modification)

Follow up: Patients will be followed for 6 months i.e 2,4,6 months. After 4th month drug intervention will be stopped and then patients will be followed for next 2 more months in order to see the reversal /non reversal of disease i.e response of body after stooping the drug.