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Starting soon Phase 2

Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial

NCT07902219 · tracked via the Priya Life Science India tracker
Sponsor
National Institute of Unani Medicine, Bengaluru
Phase
Phase 2
Started
2027-05-01
Last updated
2026-10-28

Condition(s) studied

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Investigational drug(s) / intervention(s)

Qurse RevandPlacebo

Qurse Revand: Qurse Revand (3 tablets of 835 mg each) twice daily before meals for 60 days

Placebo: placebo (wheat flour) (3 tablets of 835 mg each) twice daily before meals for 60 days,

Study summary

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, efficacy of the Unani compound formulation Qurse Revand compared to a placebo in adult participants with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Eligibility

Sex
ALL
Min age
20 Years
Max age
60 Years
Healthy volunteers
No
Inclusion criteria: * Diagnosed Cases of Fatty Liver (Grade Ⅰ \&Ⅱ) by USG. * Participants with Presence of at least 1or more cardiometabolic risk factor 1. Excess adiposity (BMI of ≥25 kg/m², Waist circumference of ≥94 cm in men and ≥80 cm in women) 2. Disorders of glucose metabolism (Prediabetes- HbA1c (5.7% to 6.4 %), FPG- 100 to 125 mg/dL, Type 2 diabetes mellitus- HbA1c of ≥6.5%; FPG of ≥126 mg/dL) 3. Hypertriglyceridemia (Plasma triglycerides ≥150 mg/dL) 4. High-density lipoprotein (HDL) cholesterol: \<40 mg/dL in men or ≤50 mg/dL in women 5. Arterial hypertension: Resting blood pressure of 130/85 mm Hg or greater or ongoing antihypertensive treatment * Participants with minimal or no alcohol intake (i.e. \<20 g/day for females and \<30 g/day for males). * Participants of any gender, aged between 20-60yrs. Exclusion criteria: * Pregnant And Lactating Mother * Fatty Liver Grade Ⅲ (by USG) * Known History of Hepatitis, Liver Cancer, systemic disorders like Malignancies, cardiovascular diseases. * Participants on medications causing steatosis (Amiodarone, Valproic Acid, Methotrexate, Tamoxifen, Glucocorticoids)

Primary outcome measure(s)

  • Change in Fatty Liver Grading by USG — From enrollment to the end of treatment at 60 Days
    Changes /decrease in fatty liver grading(from grade 1,2 to grade 0,1)by USG

Trial sites (1)

FacilityCityRegionStatus
National Institute of Unani Medicine Bangalore Bangalore Karnataka

More National Institute of Unani Medicine, Bengaluru trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07902219 on ClinicalTrials.gov ↗ ← All trials in India