Unani Intervention in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

This study is a prospective, randomized, open-label, controlled, interventional clinical trial to be conducted at the Regional Research Institute of Unani Medicine (RRIUM), Srinagar, with a sample size of 120 patients diagnosed with non-alcoholic fatty liver disease (NAFLD). The study aims to evaluate and compare the effectiveness and safety of three Unani treatment modalities—Ilaj bil Dawa (drug therapy), Ilaj bil Ghiza (dietotherapy), and Ilaj bil Tadbeer (regimenal therapy)—with standard allopathic management. Eligible participants will be randomized into four groups: Group A will receive Qurs Afsanteen with Arq Biranjasif; Group B will receive Aab Nakhood along with Qurs Afsanteen and Arq Biranjasif; Group C will receive Aab Nakhood, Qurs Afsanteen, Arq Biranjasif, and daily Riyazat; and Group D will receive Vitamin E as standard care, each for a duration of eight weeks, followed by a two-week follow-up period. The total study duration will be one year and six months, including recruitment, intervention, and follow-up. Clinical, laboratory, inflammatory, biomarker, and imaging parameters will be assessed at baseline and at the end of treatment, along with periodic clinical evaluations at predefined intervals. Primary outcomes include improvement in fatty liver grade, liver enzyme levels, and anthropometric measures, while secondary outcomes assess inflammatory markers, metabolic parameters, insulin sensitivity, quality of life, and safety. Data will be collected using validated case record forms and analyzed using appropriate statistical methods.