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COMPLETED
NCT05209633
PHASE2

Efficacy and Safety of Using Granules Dendrobii for the Treatment of Chronic Atrophic Gastritis

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

Chronic atrophic gastritis (CAG) is a common and frequently-occurring disease, characterized by atrophy of gastric mucosal epithelium and glands, thinning of the mucosa, thickening of the submucosal muscle layer, intestinal metaplasia, and atypical hyperplasia. The course of the disease is protracted and often recurrent, which seriously affects the work and physical and mental health of the patient. Moreover, epidemiological studies have shown that the risk of gastric cancer in patients with chronic multifocal atrophic gastritis is significantly higher than that of the general population. Because CAG intestinal metaplasia and dysplasia can easily develop into gastric cancer, the World Health Organization (WHO) listed CAG's gastric mucosal atrophy, intestinal metaplasia and dysplasia as precancerous lesions of gastric cancer in 1978. Therefore, reversing and disappearing the precancerous state of gastric cancer is an effective measure to prevent the occurrence of gastric cancer. The cause of CAG is complicated. Modern medicine believes that CAG is closely related to biological factors, physical and chemical factors, immune factors, and genetic factors. At present, there is no specific treatment, but symptomatic treatment is the main treatment. The disease belongs to the categories of "stomach pain" and "suffocation" in traditional Chinese medicine. In many years of surveys and studies in Mainland China, it is found that Dendrobii granules have a good effect on chronic atrophic gastritis. It is planned to explore the possibility, effectiveness and safety of Dendrobii granules in the treatment of chronic atrophic gastritis through clinical trials. 20 subjects will be randomized into the treatment group and placebo group with 18 weeks of treatment.

Official title: Efficacy and Safety of Using Granules Dendrobii for the Treatment of Chronic Atrophic Gastritis in Subjects With Deficiency of Qi and Yin: a Randomized, Double-blind, Parallel, Placebo-controlled Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-11-01

Completion Date

2024-11-22

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

DRUG

Granules Dendrobii

6g each, 3 times per day, total 18 weeks

DRUG

Placebo

placebo

Locations (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong