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

NCT05209633 | Unknown Phase 2 DMC

• 1 other identifier: Atrophic Gastritis Study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrophic Gastritis

Outcome Measures

Primary Outcomes (1)

• Change of histopathological grading of gastric mucosal atrophy.

  Measure the improvement rate of histopathological grading of gastric mucosal atrophy.

  18 weeks

Secondary Outcomes (7)

• Histopathological changes of gastric mucosa

  18 weeks

• Grading changes of gastric mucosa

  18 weeks

• Grading changes of epigastric bloating

  18 weeks

• Grading changes of epigastric pain

  18 weeks

• The efficacy of TCM syndromes

  18 weeks

Study Arms (2)

Active treatment (Granules Dendrobii)

EXPERIMENTAL

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

Drug: Granules Dendrobii

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Granules Dendrobii DRUG

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

Also known as: Dendrobii

Active treatment (Granules Dendrobii)

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Zhixiu Lin, Professor

  Hong Kong Institute of Integrative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 26, 2022
• Study Start: November 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)