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

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

• Fulfill the diagnosis of chronic atrophic gastritis;

• TCM syndrome differentiation is deficiency of both qi and yin;

• Aged between 18 and 65 years old, regardless of gender;

• Volunteer to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

• Patients with peptic ulcer, acid reflux, etc. who need PPI treatment;

• Patients with high-grade intraepithelial neoplasia of gastric mucosa or suspected malignant transformation in pathological diagnosis;

• Those who have received anti-HP treatment and related treatments in the past two weeks;

• Diabetic patients;

• Patients with severe heart, liver, kidney, lung, blood system diseases, abnormal renal function Cr test with clinical significance, and liver function ALT ≥ 1.5 times the upper limit of the normal reference value;

• People with allergies or a history of allergies to multiple drugs (two or more or the known ingredients in the drug);

• Those planning to become pregnant, pregnant or breast-feeding;

• Patients with mental illness;

• Those who have participated in other drug clinical trials within the past 3 months;

• The investigator believes that it is not suitable to participate in this clinical trial.