Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742985
Status:
COMPLETED
Last Update Posted:
2021-08-02
First Post:
2021-02-03
Brief Title:
Effects of Green Tea Extracts on Gastric Mucosal Protection
Sponsor:
Pusan National University Yangsan Hospital
Organization:
Pusan National University Yangsan Hospital
Study Overview
Official Title:
Effects of Combined Extracts of Green Tea Seed Saponins and Green Tea Leaves Epigallocatechin-3-gallate on Gastric Mucosal Protection A Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-07
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:
The investigators conduct a randomized double-blind placebo-controlled pilot study to investigate the effects of a combined extract of green tea seed saponins and green tea leaves epigallocatechin-3-gallate on gastric mucosal protection in adults with functional dyspepsia for 8 weeks
Detailed Description:
A previous study has indicated that combined extract of green tea seed saponins and green tea leaves epigallocatechin-3-gallate may improve gastric mucosal status in rat with alcohol-induced gastritisTherefore the investigators conduct a randomized double-blind placebo-controlled pilot study to investigate the effects of a combined extract of green tea seed saponins and green tea leaves epigallocatechin-3-gallate on gastric mucosal protection in adults with functional dyspepsia for 8 weeks the safety of the compound are also evaluated The Investigators examine C-reactive protein IFN-γ TNF-α gastrin malondialdehyde 8-hydroxy-2 -deoxyguanosine and questionnaires Gastrointestinal Symptom Rating Scale Nepean dyspepsia index-Korean version Nepean dyspepsia index-Korean version QOL questionnaire Gastrointestinal symptom scale at baseline and after 8 weeks of intervention Twenty four adults were administered either 320 mg of combined extracts of green tea seed saponins and green tea leaves epigallocatechin-3-gallate or a placebo each day for 8 weeks
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