This is a 2-arm, prospective, randomized, double-blind, placebo-controlled, and three-days-treatment clinical study comparing the efficacy and safety of Silfamin at a dose of 2 tablets@150 mg twice daily in subjects with common cold.
There will be 2 groups of treatment; each group will consist of 30 subjects receiving the following regimens for three days: Treatment I : 2 tablets of Silfamin 150 mg 2 times daily Treatment II : 2 tablets of Placebo 2 times daily Eligible subjects will be evaluated for treatment efficacy at 0 hours (just before drug administration), 1 and 2 hours after the first dose. For the next doses, subject will perform a self-assessment for treatment efficacy at 1 and 2 hours after every dosing, and record it in subject's diary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
2 tablets of Silfamin 150 mg twice daily
2 tablets of Silfamin Placebo twice daily
IMERI Faculty of Medicine, University of Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Makara UI Satellite Clinic
Depok, West Java, Indonesia
Score of common cold and sore throat
Score of common cold and sore throat measured at 0 hours (just before drug administration) for the first dose, 1 and 2 hours after every dosing
Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
VAS score of sore throat
VAS score of sore throat measured at 0 hours (just before drug administration), 1 and 2 hours after every dosing
Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
Adverse events
Number of adverse event, will be observed throughout the study conduct
Time frame: 1, 2, 3 days
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