A Study to Evaluate the Efficacy and Safety of a Standardized Kalmegh (Andrographis paniculata) 400 mg Capsule in comparison with Placebo, along with Ayurvedic Standard of Care (SoC), in Adults with Non-Alcoholic Fatty Liver Disease.

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicentric Clinical Study to Evaluate the Efficacy and Safety of a Standardized Kalmegh (Andrographis paniculata) 400 mg Capsule in comparison with Placebo, along with Ayurvedic Standard of Care (SoC), in Adults with Non-Alcoholic Fatty Liver Disease. - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107578

Enrollment

112

Registered

2026-04-06

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: Age 18 to 60 years inclusive of either sex Diagnosed with NAFLD by imaging Ultrasound or FibroScan Stage I or II fibrosis only able to provide informed consent Willing to comply with all study procedures, visit schedules and follow-up assessments.

Exclusion criteria

Exclusion criteria: Disease-Related Criteria: Diabetes Mellitus Alcoholic liver disease alcohol use disorder NASH with stage III fibrosis or cirrhosis Severe obesity more than or equal to 35 Kg/m2 Active infection or liver malignancy Previous or Concomitant Treatment-Related Criteria Current use of anxiolytics, hypnotics, sedatives, or antidepressants Ongoing psychotherapy or behavioural therapy for anxiety/sleep Ongoing psychotropic or hormonal medications during the study period Participation in another clinical trial or use of any investigational drug or device within 3 months prior to screening. Patient-Related Criteria Pregnancy or lactation (For Females) Women of childbearing potential not willing to use acceptable contraception History of hypersensitivity to Kalmegh or capsule ingredients Any condition that, in the investigator s opinion, may interfere with study participation or pose undue risk.

Design outcomes

Primary

Measure	Time frame
change in liver function parameters (SGOT, SGPT, bilirubin) from baseline to Day 90 using ANOVATimepoint: screening visit to day 30, 60 and 90	—

Secondary

Measure	Time frame
change in ultrasonography liver fat grading, and safety endpoints between groupsTimepoint: screening visit to day 30, 60 and 90	—

Countries

India

Contacts

Public ContactBinay Kumar Naik

Indivirtus Global CRO PVT LTD

medwriter@indivirtus.com7608847619

Outcome results