Clinical trial NCT02955134: The Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis
Official title: Follow-up Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis Based on Histological Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Atrophic Gastritis
Keywords: central blinded histological assessment
traditional Chinese medicine intervention
biological specimen banks
Lead sponsor: Wangjing Hospital, China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Shaanxi Hospital of Traditional Chinese Medicine
name: Gansu Provincial Hospital
name: Tianjin Nankai Hospital
name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Hebei Hospital of Traditional Chinese Medicine
name: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
name: Shanxi Province hospital Research Institute of Traditional Chinese Medicine
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: Shanghai University of Traditional Chinese Medicine
name: China-Japan Friendship Hospital
First posted: 2016-11-04
Enrollment: 468
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria

1. Patients diagnosed with chronic atrophic gastritis.
2. Patients whose pathological diagnosis was atrophy (reduction glands) of mild/moderate grade，with or without intestinal metaplasia, with or without mild/moderate dysplasia.
3. Aged between 40 to 65 years old, male or female.
4. Patients who agree to participate in the clinical study through informed consent.
5. Local residents ensuring regular treatment and follow-up.
6. Not taking aspirin, warfarin and other anticoagulants and those without coagulation disorders.

Exclusion criteria

1. Autoimmune gastritis.
2. The combined gastric and duodenal ulcers, upper gastrointestinal bleeding.
3. Dysplasia of severe degree,or suspicious of gastric malignancy.
4. Serious comorbidities of heart, lung, liver, kidney or blood system (such as cardiac function above grade II, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal, creatinine (Cr) greater than the upper limit of normal and so on) or having a life-threatening illness .
5. Psychiatric disorders or a history of alcohol or drug abuse.
6. Pregnant or lactating women.
7. Allergic to the trial drug.
8. Patients judged inappropriate to participate in the trial by investigators.
9. Patients enrolled in another clinical trial last two months.

Primary outcomes:
measure: Change of histological score
timeFrame: Change from baseline histological score at 6 months and 1 year
measure: Change of symptoms score
timeFrame: Change from baseline symptoms score at 6 months and 1 year
Secondary outcomes:
measure: Change of endoscopic atrophy
timeFrame: Change from baseline endoscopic atrophy at 6 months and 1 year
measure: Change of OLGA stages.
timeFrame: Change from baseline at 6 months and 1 year
measure: Change of OLGIM stages.
timeFrame: Change from baseline endoscopic atrophy at 6 months and 1 year
Other outcomes:
measure: Change of serum level of pepsinogen
timeFrame: Change from baseline serum level of pepsinogen at 6 months and 1 year
measure: Patient-Reported Outcome Instrument developed by our research group.
timeFrame: through study completion, an average of 1 month
measure: Blood routine tests
timeFrame: up to 24 weeks
measure: Electrocardiogram
timeFrame: up to 24 weeks
measure: Renal function
timeFrame: up to 24 weeks
measure: Liver function
timeFrame: up to 24 weeks
measure: Stool routine tests
timeFrame: up to 24 weeks
measure: Urine routine tests
timeFrame: up to 24 weeks
measure: Adverse events
timeFrame: up to 24 weeks
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
city: Beijing
country: China
facility: Wangjing Hospital of China Academy of Chinese Medical Sciences
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
city: Guangzhou
country: China
facility: Guangdong Provincial TCM Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
city: Lanzhou
country: China
facility: GanSu Provincial Hospital of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Affiliated Hospital of Shanghai University of Traditional Chinese Medicine
city: Shenyang
country: China
facility: Liaoning Hospital of TCM
city: Shijiazhuang
country: China
facility: Hebei Hospital of TCM
city: Taiyuan
country: China
facility: Shanxi province hospital of traditional Chinese medicine
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
city: Xi'an
country: China
facility: Shanxi Traditional Chinese Medicine Hospital
Study officials:
affiliation: Wangjing Hospital of China Academy of Chinese Medical Sciences
name: Wei Wei, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: