A Phase 2 interventional study of Silfamin and Placebo tablet of Silfamin in Common Cold and Sore-throat, sponsored by Dexa Medica Group. Completed at 2 sites in Indonesia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Dexa Medica Group · Phase 2, Interventional, and Treatment
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.
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.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 60 is below the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →Dexa Medica Group is the lead sponsor of 41 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 tablets of Silfamin 150 mg twice daily
Drug: Silfamin
2 tablets of Placebo twice daily
Drug: Placebo tablet of Silfamin
2 tablets of Silfamin 150 mg twice daily
Also known as: Herbacold
2 tablets of Silfamin Placebo twice daily
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
Time frame: 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
Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
Adverse events
Number of adverse event, will be observed throughout the study conduct
Time frame: 1, 2, 3 days
Ran from Jul 2024 to primary completion in Sep 2024, 2 months.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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