Trial reportTheScientificWorldJournal2026
Evaluating Safety and Efficacy of Bio-Immune (Andrographolide) in Managing URTI Symptoms: A Randomized, Double-Blinded, Placebo-Controlled, Single-Center, Comparative Study.
Trial report in TheScientificWorldJournal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06689995 (An Investigation of the Safety and Effectiveness of an Oral Supplementation of Bio-Immune® for Managing Upper Respiratory Tract Infection and Its Symptoms), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Investigation of the Safety and Effectiveness of an Oral Supplementation of Bio-Immune® for Managing Upper Respiratory Tract Infection and Its Symptoms: A Prospective, Interventional, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Science Study.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
introductionBio-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).
methodsParticipants 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.
resultsOf 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.
conclusionsClinical 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 registrationClinical Trial Registry of India: CTRI/2024/12/077632; ClinicalTrials.gov identifier: NCT06689995.
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