CRSU.P.Dexa/06/20/14.04

About this trial

Last updated 10 months ago

Study ID

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18 to 60 Years

All

Trial Timing

Ended 4 months ago

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.

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)

Efficacy and Safety of Silfamin for Common Cold