Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497439
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-05
Brief Title:
Efficacy and Safety of Silfamin for Common Cold
Sponsor:
Dexa Medica Group
Organization:
Dexa Medica Group
Study Overview
Official Title:
Efficacy and Safety of Silfamin for Common Cold With or Without Sore Throat Preliminary Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 tablets150 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 subjects diary
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 subjects diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None