Evaluating Safety and Efficacy of Bio-Immune (Andrographolide) in Managing URTI Symptoms: A Randomized, Double-Blinded, Placebo-Controlled, Single-Center, Comparative Study.

INTRODUCTION: Bio-Immune is a standardized extract containing andrographolide, a diterpenoid lactone derived from the aerial parts of Andrographis paniculata (commonly known as Kalmegh), and the carrier, 2-hydroxypropyl beta-cyclodextrin. Kalmegh has long been used to treat uncomplicated upper respiratory tract infection (URTI) in complementary and alternative medicine. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy of Bio-Immune (≥ 17% w/w andrographolide content). METHODS: Participants were randomized to receive either 100 mg Bio-Immune twice daily or placebo for a 5-day intervention period (Clinical trial registration number: CTRI/2024/12/077632, Registered 4, December 2024). The primary outcome measure was the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) score; secondary outcomes included Visual Analogue Scale (VAS) and Numeric Rating Scale (NRS) scores, nasal mucus weight, C-reactive protein (CRP), Interleukin-8 (IL-8), and Immunoglobulin A (IgA) in nasal wash, along with safety. RESULTS: Of 67 screened participants, 56 were enrolled, and 55 completed the study. The WURSS-21, VAS, and NRS scores in the Bio-Immune group improved, with statistically significant reductions suggesting relief from symptoms associated with uncomplicated URTI and sustained functional improvement owing to Bio-Immune supplementation. Although the placebo group showed gradual improvement over time, the speed and magnitude of recovery were consistently and statistically superior in the Bio-Immune cohort, with significant changes evident by 6 h after supplementation. Furthermore, a significant reduction in nasal mucus weight was observed by Day 5, accompanied by minor downward trends in CRP and IL-8, which lacked adequate statistical support. No adverse events were reported during the intervention period. CONCLUSIONS: Clinical findings support the efficacy of Bio-Immune at a lower dose in providing URTI symptom relief compared with placebo in a shorter intervention period. TRIAL REGISTRATION: Clinical Trial Registry of India: CTRI/2024/12/077632; ClinicalTrials.gov identifier: NCT06689995.