Efficacy and safety of AP-Bio (KalmCold) in participants with uncomplicated upper respiratory tract viral infection (common cold) - A phase III, double-blind, parallel group, randomized placebo-controlled trial
Raj JP, et al
Published in Complementary Therapies in Medicine
Methodology
Phase III double-blind, parallel-group, randomised placebo-controlled trial; 331 screened and 300 enrolled, randomised 1:1:1 to AP-Bio (KalmCold) 200 mg/day, 400 mg/day or placebo for 7 days; primary outcome the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) score, secondary outcomes nasal mucus weight, muco-ciliary clearance, nasal wash interleukin-8, safety and tolerability.
Key Findings
300 participants with the common cold were randomised 1:1:1 to Andrographis paniculata extract (AP-Bio/KalmCold) 200 mg/day, 400 mg/day or placebo for 7 days. On day 3 the WURSS-21 global symptom score was significantly lower with 400 mg (mean difference -3.85, 95% CI -6.85 to -0.85, adjusted p = 0.034) and 200 mg (-3.74, 95% CI -6.73 to -0.76, adjusted p = 0.038) than placebo, and change from baseline favoured both doses. This advantage did not persist at day 5 or day 7. Nasal mucus weight, tissue counts and interleukin-8 trended in favour of the extract but were not statistically significant. No participant reported adverse physical symptoms, though incident eosinophilia appeared in 20 people, most of them in the placebo group (13 of 20, p = 0.181).
Conclusions
Participants in both the AP-Bio dose groups showed positive tendency towards resolution of URTI symptoms when compared with placebo on Day-3 but not on Day-5 and Day-7.
Limitations
The benefit appeared only at day 3 and had disappeared by days 5 and 7, so this may reflect faster early symptom relief rather than a changed course of illness; objective measures did not reach significance and placebo scores had very wide variability.
Supplements Studied
Participants in both the AP-Bio dose groups showed positive tendency towards resolution of URTI symptoms when compared with placebo on Day-3 but not on Day-5 and Day-7.
Related Health Concerns
Study Details
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