Status:
COMPLETED
Efficacy and Safety of Silfamin for Common Cold
Lead Sponsor:
Dexa Medica Group
Collaborating Sponsors:
Fakultas Kedokteran Universitas Indonesia
Conditions:
Common Cold
Sore-throat
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 da...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06497439
Start Date
July 12 2024
End Date
September 30 2024
Last Update
February 7 2025
Active Locations (2)
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1
IMERI Faculty of Medicine, University of Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430
2
Makara UI Satellite Clinic
Depok, West Java, Indonesia, 16425