Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510257
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Safety and Efficacy Reconyl for Cough WithWithout Sore Throat
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Reconyl for Cough WithWithout Sore Throat A 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective randomized double-blind and placebo-controlled study to find out if reconyl may relieve the acute cough withwithout sore throat
Detailed Description:
Reconyl is a mixed extract from 4 Indonesian herbs Vitex trifolia Legundi Zingiber officinale var Amarum Jahe Gajah Abrus precatorius Saga and Phaleria macrocarpa Mahkota Dewa which have been known traditionally to relieve cough respiratory congestion and sore throat
There will be two parallel groups of 30 subjects per group a total of 60 subjects planned to be enrolled in this study
The investigational product tablets 225 mg of Reconyl Dose administration One tablet of Reconyl or Placebo given 3 times daily for 3 days
Eligible subjects will be instructed to perform a daily self-assessment on the cough symptoms over the 3 days of treatment in the Subject Diary Subject shall return to the study clinic 3 days 24 hours after the first dose for completion of the subjects participation in the study
There will be two parallel groups of 30 subjects per group a total of 60 subjects planned to be enrolled in this study
The investigational product tablets 225 mg of Reconyl Dose administration One tablet of Reconyl or Placebo given 3 times daily for 3 days
Eligible subjects will be instructed to perform a daily self-assessment on the cough symptoms over the 3 days of treatment in the Subject Diary Subject shall return to the study clinic 3 days 24 hours after the first dose for completion of the subjects participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None