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| Name | Class |
|---|---|
| Fakultas Kedokteran Universitas Indonesia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silfamin | Experimental | 2 tablets of Silfamin 150 mg twice daily |
|
| Placebo | Placebo Comparator | 2 tablets of Placebo twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silfamin | Drug | 2 tablets of Silfamin 150 mg twice daily |
|
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of adverse event, will be observed throughout the study conduct | 1, 2, 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMERI Faculty of Medicine, University of Indonesia | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia | ||
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo tablet of Silfamin | Drug | 2 tablets of Silfamin Placebo twice daily |
|
| Makara UI Satellite Clinic |
| Depok |
| West Java |
| 16425 |
| Indonesia |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |