Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378099
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-17
Brief Title:
Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments
Sponsor:
Universidad de Antioquia
Organization:
Universidad de Antioquia
Study Overview
Official Title:
Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments in Drugstores and DrugstoresPharmacies in Medellin and the Metropolitan Area Colombia InFaPro a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
InFaPro
Brief Summary:
Minor ailments are non-serious short-term health problems not related to the patients pathologies or to the desired or undesired effects of the medications they are taking Pharmaceutical indication is the service provided in response to a patients request who comes to the pharmacy asking for a medication recommendation for a health problem for this purpose over-the-counter medications are used which are pharmacological agents that can be acquired without a prescription The practice of pharmaceutical indication turns self-medication into a safe and responsible practice but it requires agreed-upon protocols
Detailed Description:
This study is an experimental investigation with a baseline reference period involving parallel groups of patients who approach a drugstore or drugstorepharmacy to purchase over-the-counter medication for the treatment of a possible minor ailment Drugstores or drugstorespharmacies will be selected using cluster sampling and patients will be randomly allocated to one of the study groups intervention or control The intervention group will receive care in line with the consensus pharmaceutical indication protocols and will undergo follow-up on days 3 to 5 and 7 to 10 post-care the control group will continue with the standard care procedure The aim of this study is to assess whether the implementation of consensus pharmaceutical indication protocols can shorten the resolution time of minor ailments and reduce the frequency of referrals to physicians Secondary outcomes include 1 profiling the population that visits a drugstore or drugstorepharmacy to purchase an over-the-counter medication for a minor ailment 2 identifying and classifying the minor ailment and 3 determining the necessity for over-the-counter medication to address the minor ailment
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