Efficacy and Safety of Silfamin for Common Cold

NCT06497439 | Completed Phase 2

• 1 other identifier: CRSU.P.Dexa/06/20/14.04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Common Cold; Sore-throat

Keywords

Common Cold; Sore-throat; Silfamin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse events

  1, 2, 3 days

Study Arms (2)

Silfamin

EXPERIMENTAL

2 tablets of Silfamin 150 mg twice daily

Drug: Silfamin

Placebo

PLACEBO COMPARATOR

2 tablets of Placebo twice daily

Drug: Placebo tablet of Silfamin

Interventions

Silfamin DRUG

2 tablets of Silfamin 150 mg twice daily

Also known as: Herbacold

Silfamin

Placebo tablet of Silfamin DRUG

2 tablets of Silfamin Placebo twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dexa Medica Group: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator

Study Sites (2)

IMERI Faculty of Medicine, University of Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Makara UI Satellite Clinic

Depok, West Java, 16425, Indonesia

Location

MeSH Terms

Conditions

Common Cold; Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 11, 2024
• Study Start: July 12, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

ID (2)