Efficacy and Safety of Silfamin for Common Cold

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

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.

Study Overview

• Status: Completed
• Conditions: Common Cold; Sore-throat
• Intervention / Treatment: Drug: Silfamin; Drug: Placebo tablet of Silfamin

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • IMERI Faculty of Medicine, University of Indonesia
  • Jawa Barat
    • Depok, Jawa Barat, Indonesia, 16425
      • Makara UI Satellite Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silfamin; 2 tablets of Silfamin 150 mg twice daily	Drug: Silfamin; 2 tablets of Silfamin 150 mg twice daily; Other Names: Herbacold
Placebo Comparator: Placebo; 2 tablets of Placebo twice daily	Drug: Placebo tablet of Silfamin; 2 tablets of Silfamin Placebo twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of adverse event, will be observed throughout the study conduct	1, 2, 3 days

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Collaborators: Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Common Cold; Sore-throat; Silfamin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Common Cold; Pharyngitis
• Other Study ID Numbers: CRSU.P.Dexa/06/20/14.04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No