Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

Chronic Atrophic Gastritis Clinical Trial

Official title:

Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493124
• Other study ID #: 2021-ZXFZJJ-035
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the efficacy and safety of "Manpixiao" in the treatment of Chronic Atrophic Gastritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The age is 18-75 years old, regardless of gender;
• Before treatment, the patients were diagnosed as chronic atrophic gastritis (with intestinal metaplasia and dysplasia) by gastroscopy and pathological examination, which met the criteria of the Chinese consensus on chronic gastritis (2017, Shanghai);
• Sign the informed consent form.

Exclusion Criteria:

• Patients with autoimmune gastritis (chronic atrophic gastritis type A), peptic ulcer (a1-h2), reflux esophagitis, gastric polyps, hypertrophic gastritis and other diseases;
• Patients with high-grade intraepithelial neoplasia of gastric mucosa, suspected malignant change of gastrointestinal mucosal lesions, and gastrointestinal tumors;
• Patients with malignant tumors who have undergone surgery, radiotherapy and chemotherapy in recent 5 years;
• Patients with primary diseases such as heart, brain, lung, hematopoietic system and malignant tumors, and subjects with severe diabetes;
• Patients with chronic liver and kidney dysfunction before treatment, including ALT > 1.5 times the upper limit of normal value, blood creatinine (CR) > 1.5 times the upper limit of normal value, and platelets lower than 1.5 times the lower limit of normal value;
• Disabled subjects specified by law (blind, deaf, dumb, intellectual, mental, physical disabilities);
• The description of self symptoms is unclear or the investigation is not the author;
• Have a history of alcohol abuse;
• Allergic constitution or a history of allergy to multiple drugs (more than two or known ingredients in the drug);
• Pregnant or lactating women;
• According to the judgment of the researcher, other reasons should not be selected.

Related Conditions & MeSH terms

• Atrophy
• Chronic Atrophic Gastritis
• Gastritis
• Gastritis, Atrophic

Intervention

Drug:
• Manpixiao
A traditional Chinese medicine composition
• Active comparator
Other drugs that may have therapeutic effects

Locations

Country	Name	City	State
China	Dongfang Hospital, Beijing University of Chinese Medicine	Beijing
China	Dongzhimen Hospital, Beijing University of TCM	Beijing
China	Zaozhuang Hospital, Beijing University of Chinese Medicine	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological improvement rate of gastric mucosa	Pathological diagnosis of gastric mucosal tissue samples obtained by gastroscopy	The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.
Secondary	Gastric mucosal status under gastroscope	For the color of gastric mucosa, spots, erosion, bleeding, reduced folds, visible blood vessels and mucosal texture, 0, 1, 2 and 3 points are given according to the levels of none, I, II and III respectively, and 0 and 1 points are given according to the presence or absence of bile reflux. According to the gastroscopy report, score the patients' microscopic results before and after treatment, and take the result change as the secondary index of curative effect. A lower score means a better result.	The enrollment inspection shall be completed within one month before enrollment; The examination after treatment should be carried out within 1 month after the completion of treatment.
Secondary	Score of main symptoms of stomach system	Adopt the "table of main symptoms of stomach system based on doctor's report", the specific contents are: epigastric (epigastric) pain, epigastric (epigastric) distension, epigastric (epigastric) blockage, heartburn, acid reflux, belching, anorexia, reduced appetite. Score 0, 1, 2 and 3 points for the severity of each single symptom (none, mild, moderate and severe). The total score of symptoms is the sum of the individual scores. By comparing the changes of individual symptom scores and total symptom scores between groups, lower scores mean better results.	They were evaluated on the day of enrollment and the day of the end of the treatment process