Clinical Trial: The Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Follow-up Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis Based on Histological Evaluation

Brief Summary: The purpose of this study is to evaluate long-term efficacy of Chinese medicine treatment for chronic atrophic gastritis. It is a multi-center, randomized, placebo-controlled trial.

Detailed Summary:

A prospective, double-blind, randomized, placebo-controlled, multi-center trial is carried out in this study.The sample size is 468 patients ( 312 in experimental group, 156 in control group). The investigators will screen the patients for inclusion according to the inclusion and exclusion criteria. All patients undergo carbon-13 labeled urea breath test, 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 experimental group or control group with an allocation ratio of 2:1. Patients in experimental 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.

Current Primary Outcome: Change of histological score [ Time Frame: Change from baseline histological score at 6 months and 1 year ]

Original Primary Outcome: Change of histological score [ Time Frame: Change from baseline histological score at 1 year ]

Current Secondary Outcome:

• Change of endoscopic atrophy [ Time Frame: Change from baseline endoscopic atrophy at 6 months and 1 year ]
  Endoscopic atrophy are defined using an endoscopicatrophic border scale previously reported by Kimura and Takemoto. This scale correlates with histological results and includes the following classifications: 1 close-type, when the atrophic border remains on the lesser curvature of the stomach; 2 open-type, when the atrophic border extends along the anterior and posterior walls of the stomach and is not associated with the lesser curvature of the stomach. Close-type and open-type atrophy are further classified as none (C0), mild (C1, 2),moderate (C3, O1), and severe (O2, 3) atrophy. In this study, atrophy grade are also scored as C0: 0, C1: 1, C2: 2, C3:3, O1: 4, O2: 5, and O3: 6 respectively, with 0 representing an absence of atrophy and 6 indicating severe atrophy.
• Change of symptoms score [ Time Frame: Change from baseline symptoms score at 6 months and 1 year ]

  Symptoms of dyspepsia, regurgitation and defecation are assessed for severity and frequency at enrollment in every interview during the study.For each symptom, the scores are calculated by multiplying frequency by severity.

  All symptom scores are added to define the total symptom score.

Original Secondary Outcome:

• Change of endoscopic atrophy [ Time Frame: Change from baseline endoscopic atrophy at 1 year ]
  Endoscopic atrophy are defined using an endoscopicatrophic border scale previously reported by Kimura and Takemoto. This scale correlates with histological results and includes the following classifications: 1 close-type, when the atrophic border remains on the lesser curvature of the stomach; 2 open-type, when the atrophic border extends along the anterior and posterior walls of the stomach and is not associated with the lesser curvature of the stomach. Close-type and open-type atrophy are further classified as none (C0), mild (C1, 2),moderate (C3, O1), and severe (O2, 3) atrophy. In this study, atrophy grade are also scored as C0: 0, C1: 1, C2: 2, C3:3, O1: 4, O2: 5, and O3: 6 respectively, with 0 representing an absence of atrophy and 6 indicating severe atrophy.
• Change of symptoms score [ Time Frame: Change from baseline symptoms score at 1 year ]

  Symptoms of dyspepsia, regurgitation and defecation are assessed for severity and frequency at enrollment in every interview during the study.For each symptom, the scores are calculated by multiplying frequency by severity.

  All symptom scores are added to define the total symptom score.

Dates:
Date Received: October 28, 2016
Date Started: December 2016
Date Completion: May 2020
Last Updated: November 15, 2016
Last Verified: October 2016