Results:
The efficacy was evaluated on the basis of visual analogue scale scores of various symptoms of URTI, like cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue and sleep disturbance on day 1, 3 and 5.
In both the groups (placebo and KALMCOLDTM ), mean scores of all symptoms showed a decreasing trend from day 1 to day 3 and day 5 but from day 3 to day 5 most of the symptoms in placebo treated group either remained constant (cough, headache and earache) or got aggravated (sore throat and sleep disturbance) whereas in KALMCOLDTM treated group all symptoms showed a decreasing trend.
The comparison of effect of KALMCOLDTM over placebo was found to be significant (p ≤ 0.05) for all parameters except earache and the overall effect size of KALMCOLDTM on symptoms was found to be significant (p ≤ 0.05) and 2.1 times or 52.7% higher than placebo.
The study had low level of adverse events in both KALMCOLDTM and placebo groups.
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