The Study of Chinese Medicine for the Treatment of Chronic Atrophic Gastritis

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wangjing Hospital, China Academy of Chinese Medical Sciences
• Collaborators: Beijing Hospital of Traditional Chinese Medicine; Beijing University of Chinese Medicine; First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; Gansu Provincial Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Hebei Hospital of Traditional Chinese Medicine; Liaoning Hospital of TCM; Shaanxi Hospital of Traditional Chinese Medicine; Shanghai University of Traditional Chinese Medicine; Shanxi Hospital of Traditional Chinese Medicine; Shanxi Province hospital Research Institute of Traditional Chinese Medicine; ShenZhen AiUYi Health Management Co.,Ltd; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital; Tianjin Nankai Hospital; Xiyuan Hospital of China Academy of Chinese Medical Sciences; Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine
• Treatments: Hydrotalcite

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.