Efficacy and Safety of Silfamin for Common Cold

Dexa Medica

Status and phase: Completed; Phase 2

Conditions: Sore-throat; Common Cold

Treatments: Drug: Silfamin; Drug: Placebo tablet of Silfamin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06497439

CRSU.P.Dexa/06/20/14.04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Silfamin

Experimental group

Description:

2 tablets of Silfamin 150 mg twice daily

Treatment:

Drug: Silfamin

Placebo

Placebo Comparator group

Description:

2 tablets of Placebo twice daily

Treatment:

Drug: Placebo tablet of Silfamin