Efficacy and Safety of Silfamin for Common Cold

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Common Cold Sore-throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Silfamin

2 tablets of Silfamin 150 mg twice daily

Group Type EXPERIMENTAL

Silfamin

Intervention Type DRUG

2 tablets of Silfamin 150 mg twice daily

Placebo

2 tablets of Placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo tablet of Silfamin

Intervention Type DRUG

2 tablets of Silfamin Placebo twice daily

Interventions

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Silfamin

2 tablets of Silfamin 150 mg twice daily

Intervention Type DRUG

Placebo tablet of Silfamin

2 tablets of Silfamin Placebo twice daily

Intervention Type DRUG

Other Intervention Names

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Herbacold

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes