Common Cold, Sore-throat
Conditions
Keywords
Common Cold, Sore-throat, Silfamin
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.
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.
Interventions
DRUGSilfamin
2 tablets of Silfamin 150 mg twice daily
DRUGPlacebo tablet of Silfamin
2 tablets of Silfamin Placebo twice daily
Sponsors
Fakultas Kedokteran Universitas Indonesia
Dexa Medica Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of common cold and sore throat | 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days | 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 |
| VAS score of sore throat | 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days | VAS score of sore throat measured at 0 hours (just before drug administration), 1 and 2 hours after every dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 1, 2, 3 days | Number of adverse event, will be observed throughout the study conduct |
Countries
Indonesia
Outcome results
None listed