CompletedPhase 2

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

Hong Kong20 participantsStarted 2022-11-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of histopathological grading of gastric mucosal atrophy.

Timeframe: 18 weeks

Trial details

NCT IDNCT05209633

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-22

View on ClinicalTrials.gov More Atrophic Gastritis trials