Effect of Kalmegh and Amalaki on cases of Fatty Liver Disease

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108577

Enrollment

Registered

2026-04-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 scanTimepoint: 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.	—

Measure

Time frame

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 scanTimepoint: 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.

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Secondary

Measure	Time frame
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 scanTimepoint: 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.	—

Measure

Time frame

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 scanTimepoint: 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.

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Countries

India

Contacts

Public ContactDr Sunil Kumar

Institute of Medical Science

drnitish1898@bhu.ac.in6265247572

Outcome results