Efficacy and Safety of Silfamin for Common Cold

Phase 2

Completed

• Conditions: Common Cold; Sore-throat
• Interventions: Drug: Silfamin; Drug: Placebo tablet of Silfamin

• Registration Number: NCT06497439
• Lead Sponsor: Dexa Medica Group

Brief 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.

Study Timeline

• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-05
• Study First Posted: 2024-07-11
• Study Start: 2024-07-12
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Otherwise healthy (by anamnesis) men or women aged 18 to 60 years with mild or moderate common cold with or without sore throat (Common cold Score of 1 or 2)
• Willing to participate in the study by signing the informed consent

Exclusion Criteria

• Body temperature of > 37.3˚C and/or refuse to follow health protocol for COVID-19
• Known hypersensitivity to herbal drugs containing Nigella sativa and/or Phaleria macrocarpa
• Pregnant or lactating women
• Have received any analgesic, anti-inflammatory or other common cold preparation within the past 24 hours
• Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
• Severe illness, e.g. severe hypertension (> 160/100 mmHg)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silfamin	Silfamin	2 tablets of Silfamin 150 mg twice daily
Placebo	Placebo tablet of Silfamin	2 tablets of Placebo twice daily

Primary Outcome Measures

Name	Time	Method
Score of common cold and sore throat	30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days	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
VAS score of sore throat	30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days	VAS score of sore throat measured at 0 hours (just before drug administration), 1 and 2 hours after every dosing

Secondary Outcome Measures

Name	Time	Method
Adverse events	1, 2, 3 days	Number of adverse event, will be observed throughout the study conduct

Trial Locations

Locations (2)

Makara UI Satellite Clinic; 🇮🇩 Depok, Jawa Barat, Indonesia

IMERI Faculty of Medicine, University of Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia