A DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, PLACEBO-CONTROLLED, COMPARATIVE STUDY FOR ASSESSING THE EFFICACY AND TOLERABILITY OF ANDROPANTM IN INDIVIDUALS WITH UPPER RESPIRATORY INFECTION WITH OR WITHOUT STANDARD OF CARE

*Mr. Nimish Dudhatra, Mr. Viraj Patel, Dr. Ghanshyam Patel, Dr. Mehul Marwadi, Dr. Krunali Dhorajiya

ABSTRACT

Background: Upper respiratory tract infections (URTIs) impose a significant clinical burden despite being generally self-limiting. AndroPanTM, a standardized extract of Andrographis paniculata, is traditionally recognized for its immunomodulatory properties. This comprehensive Phase II randomized, double-blind, placebo-controlled study evaluates the efficacy, safety, and tolerability of AndroPanTM in URTI management. Methods: The study used a double-blind, randomized, placebo-controlled, parallel-group design to assess the effectiveness of an investigational product (IP) in treating a condition. 38 subjects were randomly assigned in a 1:1 ratio, with the goal of obtaining complete data from at least 30. The screening period involved various procedures, including obtaining written informed consent, recording demographic information, and conducting clinical examinations. The study continued with follow-up visits, IP compliance checks, and global assessment scales. The study concluded if no adverse events were reported or if all reported adverse events were resolved. Results: LCQ scores significantly improved in the AndroPanTM group by 99.7% compared to 20.8% in placebo (p<0.05). Complete symptom resolution was achieved by 15.8% of the AndroPanTM group. No adverse events were reported. Global Assessment Scores confirmed high tolerability. Conclusion: AndroPanTM demonstrates significant efficacy in symptomatic relief of URTI, with excellent safety and tolerability. These findings encourage further larger-scale studies.

Keywords: Upper Respiratory Tract Infection, Randomized Controlled Trial, Immunomodulatory, Andrographis paniculata.