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Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

Primary Purpose

Chronic Atrophic Gastritis

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Manpixiao
Active comparator
Sponsored by
Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Atrophic Gastritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dongfang Hospital, Beijing University of Chinese MedicineRecruiting
  • Dongzhimen Hospital, Beijing University of TCMRecruiting
  • Zaozhuang Hospital, Beijing University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

Manpixiao treatment group

Blank treatment group

Active comparator

Arm Description

A traditional Chinese medicine composition (has applied for Chinese patent)，Take 17.15g daily, twice in the morning and evening, for a total of 24 weeks

Including treated with Chinese patent drugs such as Weifuchun and morodan, or treated with antacids, motivational drugs, gastric mucosal protectants, vitamins, folic acid, selenium containing preparations and other drugs. Take it according to the instructions.

Outcomes

Primary Outcome Measures

Pathological improvement rate of gastric mucosa
Pathological diagnosis of gastric mucosal tissue samples obtained by gastroscopy

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 29, 2022
Last Updated
August 5, 2022
Sponsor
Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05493124
Brief Title
Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis
Official Title
Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Atrophic Gastritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manpixiao treatment group
Arm Type
Experimental
Arm Description
A traditional Chinese medicine composition (has applied for Chinese patent)，Take 17.15g daily, twice in the morning and evening, for a total of 24 weeks
Arm Title
Blank treatment group
Arm Type
No Intervention
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Including treated with Chinese patent drugs such as Weifuchun and morodan, or treated with antacids, motivational drugs, gastric mucosal protectants, vitamins, folic acid, selenium containing preparations and other drugs. Take it according to the instructions.
Intervention Type
Drug
Intervention Name(s)
Manpixiao
Intervention Description
A traditional Chinese medicine composition
Intervention Type
Drug
Intervention Name(s)
Active comparator
Intervention Description
Other drugs that may have therapeutic effects
Primary Outcome Measure Information:
Title
Pathological improvement rate of gastric mucosa
Description
Pathological diagnosis of gastric mucosal tissue samples obtained by gastroscopy
Time Frame
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 Outcome Measure Information:
Title
Gastric mucosal status under gastroscope
Description
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.
Time Frame
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.
Title
Score of main symptoms of stomach system
Description
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.
Time Frame
They were evaluated on the day of enrollment and the day of the end of the treatment process

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dongfang Hospital, Beijing University of Chinese Medicine
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Ding
Phone
13611184842
Email
dingx@bucm.edu.cn
Facility Name
Dongzhimen Hospital, Beijing University of TCM
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Ding
Phone
13611184842
Email
dingx@bucm.edu.cn
Facility Name
Zaozhuang Hospital, Beijing University of Chinese Medicine
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Ding
Phone
13611184842
Email
dingx@bucm.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Obtained by asking the first or correspondent author if necessary
IPD Sharing Time Frame
One year after the completion of the study
IPD Sharing Access Criteria
Obtained by asking the first or correspondent author if necessary

Learn more about this trial

Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis

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