Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
Study NCT ID:
NCT06005805
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea: to Evaluate the Effect of Mastic Gum in Participants With Functional Dyspepsia Symptoms
Status:
COMPLETED
Status Verified Date:
2023-11
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:
The goal of this study is to evaluate the feasibility of a decentralized clinical trial in South Korea. The main questions it aims to answer are:
* Does decentralized elements feasible in Korea?
* Does Mastic gum alleviates symptoms and modifies stool microbiome in Korean patients with functional dyspepsia?
* Does decentralized elements feasible in Korea?
* Does Mastic gum alleviates symptoms and modifies stool microbiome in Korean patients with functional dyspepsia?
Detailed Description:
The trial aims to evaluate decentralized elements in South Korea, including clinical laboratory testing using local laboratories, medication adherence assessment using wearable devices, analysis of self-kit specimens, delivery and tracking of investigational medication, real-time remote interview of subjects and e-consent acquisition.
Mastic gum is registered with the Ministry of Food and Drug Safety in South Korea as a dietary supplement for gastric health, and the study aims to explore the effect on the gastrointestinal symptoms and composition of the stool microbiome.
Mastic gum is registered with the Ministry of Food and Drug Safety in South Korea as a dietary supplement for gastric health, and the study aims to explore the effect on the gastrointestinal symptoms and composition of the stool microbiome.
Study Oversight
Has Oversight DMC:
False
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?: