Efficacy and Safety of Phyllanthus Emblica and Tinospora Cordifolia in Postadolescence Acne: A Randomized Double-Blind Placebo-Controlled Trial

INTRODUCTION: ) and widely incorporated them into formulations for dermatological disorders. Their therapeutic effects have been attributed to a range of bioactive phytochemical constituents identified in herbal extracts. Acne leads to poor quality of life (QoL), and available treatment protocols are varied and suboptimal and often lead to adverse events. The aim of the study was to evaluate the efficacy and safety of a herbal formulation comprising PE and TC in patients with mild to moderate acne. METHODS: An investigator-initiated, randomized, double-blind, placebo-controlled, dose-ranging clinical trial. Eighty-eight volunteers with postadolescent acne were randomized to receive the standardized oral PE and TC formulation named Link Natural Swastha Amurtha (LNSA) at doses of 300 mg, 400 mg, or 500 mg daily, or a placebo, for 12 weeks. The primary endpoint of the study was the change in total acne lesion counts from baseline to 12 weeks. Secondary endpoints included changes in inflammatory and noninflammatory lesion counts, acne severity, sebum production, and QoL. Safety was assessed through hematological, hepatic, and renal laboratory parameters, along with monitoring of adverse events. RESULTS: A dose-dependent reduction in acne lesion counts was observed in participants receiving LNSA; however, differences between the treatment and placebo groups did not reach statistical significance. All three LNSA dosage groups demonstrated statistically significant improvements in QoL compared with baseline. Laboratory safety parameters remained within normal reference ranges throughout the study, and no serious or treatment-related adverse events were reported. CONCLUSIONS: LNSA was found to be safe and well tolerated, with dose-related beneficial effects. The significant improvement in patient-reported QoL is a noteworthy outcome. Further adequately powered studies are warranted to explore the clinical efficacy of LNSA as a standalone or adjunctive therapy in acne management and laboratory studies to determine the mode of action of these plant constituents. (The study was registered in the Clinical Trials Registry in Sri Lanka (International Clinical Trial Registration Platform: SLCTR/2022/025), a member of the Primary Registry of the World Health Organization. https://slctr.lk/trials/slctr-2022-025).