Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 9:40 AM
Study NCT ID:
NCT02955134
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2016-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis
Sponsor:
Wangjing Hospital, China Academy of Chinese Medical Sciences
Organization:
Study Overview
Official Title:
Follow-up Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis Based on Histological Evaluation
Status:
COMPLETED
Status Verified Date:
2022-02
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 purpose of this study is to evaluate efficacy of Chinese medicine treatment for chronic atrophic gastritis. It is a multi-center, randomized, placebo-controlled trial.
Detailed Description:
A prospective, double-blind, randomized, placebo-controlled, multi-center trial is carried out in this study.The sample size is 468 patients ( 312 in treatment group, 156 in control group). The investigators will screen the patients for inclusion according to the inclusion and exclusion criteria. All patients detect of H.pylori, undergo upper digestive endoscopy and biopsies for histological investigation. Patients infected of H.pylori must receive H.pylori eradication therapy under the guidance of Kyoto global consensus report on H.pylori gastritis. Then they are assigned to treatment group or control group with an allocation ratio of 2:1. Patients intreatment group take the traditional Chinese medicine prescription, while the control group take simulate granule of the prescription. Both two groups are under symptomatic treatment. Treatment duration lasts 24 weeks. Investigators also follow up another 24 weeks. Histological changes are used as the primary outcome index. Endoscopy findings, symptoms are assessed. Serum level of pepsinogen and patient-reported outcome instrument are also administered during the study. All biopsy specimens are collected to build the biological specimen bank. Central blinded histological assessment (Histological diagnosis is determined independently by three experienced pathologists who are blinded to the information of the patients.) are used to insure the accuracy and consistency. Tele-medicine and information management system is established to help achieve follow-up interviews.
Random numbers are generated by SAS 9.4 software. The subjects, caregivers, investigators and outcomes assessors in this study are all blinded.
Random numbers are generated by SAS 9.4 software. The subjects, caregivers, investigators and outcomes assessors in this study are all blinded.
Study Oversight
Has Oversight DMC:
True
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?: