Clinical trial of Ayush-GMH formulation for Non-alcoholic fatty liver disease

Evaluation of Ayush-GMH in the Subjects of Mild to Moderate Non alcoholic Fatty Liver Disease (NAFLD) A Double Blind Randomized Control Clinical Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/042985

Enrollment

100

Registered

2022-06-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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: 1 Diagnosed cases of Grade I and II of nonalcoholic fatty liver disease as evident fatty infiltration on Ultrasound 2 Subjects of nonalcoholic fatty liver disease with their hepatic enzymes ranging within normal limits defined as AST 5-40U/L and ALT 7-56U/L 3 Willing and able to participate for 6 months in the study.

Exclusion criteria

Exclusion criteria: 1 Any other identified cause of chronic liver disease 2 The prescription of medication which would cause non alcoholic fatty liver disease (exa. tamoxifen) 3 Already taking supplementary medicine for NAFLD 4 History of habitual consumption of alcohol intake of more than 20g/day for women, more than 40g/day for men 5 On anticoagulant(antiplatelets are permitted) 6 Subjects who have a past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 7 Symptomatic patients with clinical evidence of congestive cardiac failure. 8 Subjects with concurrent Renal Dysfunction (defined as S. creatinine more than 1.2 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 9 Uncontrolled Diabetes Mellitus(HbA1C more than 8) 10 Known cases of HIV and AIDS. 11 Known cases of malignancy 12 Known case of Hepatitis B 13 Subjects taking participation in any other clinical trial. 14 Women who are planning for conception, pregnant or lactating. 15 Any other condition which the PI thinks may jeopardize the study.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of Ayush-GMH in the patients of NAFLD on sonological parameters by USG abdomenTimepoint: Screening, 90 and 180 days	—

Secondary

Measure	Time frame
To assess changes in ALT, AST, Serum bilirubin, Total proteins and Alkaline PhosphataseTimepoint: Screening, 90 and 180 days;To measure change in Fatty liver indexTimepoint: Screening, 90 and 180 days;To assess quality of life with Health survey questionnaire RAND SF36Timepoint: Screening, 90 and 180 days;To assess any biological intolerability or adverse eventsTimepoint: Each visit	—

Countries

India

Contacts

Public ContactDr Pradeep Grampurohit

ICMR National Institute of Traditional Medicine Belagavi

barvaliya.m@icmr.gov.in08312475477

Outcome results