Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05916768
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-06-23
First Post:
2023-06-14
Brief Title:
Management of Acute Bronchitis With Pelargonium Sidoides Extract
Sponsor:
University of Fribourg
Organization:
University of Fribourg
Study Overview
Official Title:
Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs7630 Versus Usual Care - a Pragmatic Open-label Randomised Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-06
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:
Phytobronch
Brief Summary:
The aim of our study is to conduct a pragmatic RCT meeting all required standards to evaluate the effectiveness of Pelargonium sidoides extract EPs 7630 in the management of acute bronchitis with or without COVID-19 in PCP practices and walk-in clinics in French-speaking Switzerland The RCT will be preceded by a pilot phase to ensure its feasibility
Detailed Description:
The goal of this clinical trial is to evaluate the effectiveness of Pelargonium sidoides extract EPs 7630 also known under the brand name Kaloba in the management of acute bronchitis
The main questions it aims to answer are
Is Pelargonium sidoides extract EPs 7630 effective to reduce the severity and the duration of symptoms related to acute bronchitis
Does Pelargonium sidoides extract EPs 7630 allow to reduce the prescription of antibiotics
Participants will be randomize 11 either in the control group usual care or in the intervention group Pelargonium sidoides extract EPs 7630
The main questions it aims to answer are
Is Pelargonium sidoides extract EPs 7630 effective to reduce the severity and the duration of symptoms related to acute bronchitis
Does Pelargonium sidoides extract EPs 7630 allow to reduce the prescription of antibiotics
Participants will be randomize 11 either in the control group usual care or in the intervention group Pelargonium sidoides extract EPs 7630
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