NCT06497439

Efficacy and Safety of Silfamin for Common Cold

Efficacy and Safety of Silfamin for Common Cold With or Without Sore Throat: Preliminary Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Common Cold
• Sore-throat

Interventions

Type	Name	Description
DRUG	Silfamin	2 tablets of Silfamin 150 mg twice daily
DRUG	Placebo tablet of Silfamin	2 tablets of Silfamin Placebo twice daily

Timeline

• Start date: 2024-07-12
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2024-07-11
• Last updated: 2025-02-07

Locations

2 sites across 1 country: Indonesia