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Clinical Study and Molecular Mechanism of Spleen and Stomach Peiyuan Decoction in the Treatment of Chronic Atrophic Gastritis with Intestinal Metaplasia

Registration number：

ITMCTR2025000511

Date of Last Refreshed on：

2025-03-11

Date of Registration：

2025-03-11

Registration Status：

Retrospective registration

Public title：

Clinical Study and Molecular Mechanism of Spleen and Stomach Peiyuan Decoction in the Treatment of Chronic Atrophic Gastritis with Intestinal Metaplasia

English Acronym：

Scientific title：

Clinical Study and Molecular Mechanism of Spleen and Stomach Peiyuan Decoction in the Treatment of Chronic Atrophic Gastritis with Intestinal Metaplasia

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xuejun Li

Study leader：

Xuejun Li

Applicant telephone：

15755234412

Study leader's telephone：

15755234412

Applicant Fax：

Study leader's fax：

Applicant E-mail：

15755234412@163.com

Study leader's E-mail：

15755234412@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Meishan Road Campus, Anhui University of Traditional Chinese Medicine, Shushan District, Hefei City, Anhui Province, China

Study leader's address：

Meishan Road Campus, Anhui University of Traditional Chinese Medicine, Shushan District, Hefei City, Anhui Province, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2022-zj-20

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Date of approved by ethic committee：

2022/4/29 0:00:00

Contact Name of the ethic committee：

Yinzi Shu

Contact Address of the ethic committee：

No.300 Shouchun Road, Luyang District, Hefei City, Anhui Province, China

Contact phone of the ethic committee：

0551-62668814

Contact email of the ethic committee：

ahzjyykik@163.com

Primary sponsor：

Department of Spleen and Stomach The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine China

Primary sponsor's address：

Meishan Road Campus Anhui University of Traditional Chinese Medicine Shushan District Hefei City Anhui Province China

Secondary sponsor：

Country：

China

Province：

An Hui

City：

Hefei

Institution
hospital：

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Address：

No.300 Shouchun Road Luyang District Hefei City Anhui Province China

Source(s) of funding：

Collaborative Research Project of Chinese and Western Medicine for Major Difficult Diseases in Anhui Province 0708-2021

Target disease：

Chronic atrophic gastritis with intestinal metaplasia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

A clinical study was conducted to evaluate the efficacy of Spleen and Stomach Peiyuan Formula Plus Reduction combined with moxa strips in the treatment of CAG with intestinal adenomatous metaplasia bed; and to apply endoscopic examination and scale assessment (improvement in clinical symptom scores; and improvement in prognosis reported by subjects) to reveal the biological mechanism of Spleen and Stomach Peiyuan Formula Plus Reduction combined with moxa strips in the treatment of CAG with intestinal adenomatous metaplasia bed.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Those who meet the diagnostic criteria by endoscopy and pathological tissue biopsy; (2) Those who have stable vital signs after conventional treatment and the duration of the disease is less than 3 months; (3) Those with clinical manifestations of the digestive tract such as abdominal distension abdominal pain gastric discomfort belching and acid reflux; (4) Those who voluntarily participate in this clinical trial give informed consent and sign the informed consent form; (5) Aged 18 to 75 years old gender is not limited; (6) Those with complete clinical data.

Exclusion criteria：

(1) Patients who have taken proton pump inhibitors (PPIs) and other drugs that may affect the function of the digestive tract within the last 2 weeks; (2) Patients who have taken antibiotics in the last 1 month; (3) Those who have a combination of serious digestive tract haematological neurological malignancies and other primary diseases; (4) Patients with conscious disorders; (5) Those with cognitive dysfunction; (6) Those with severe multi-organ failure; (7) Patients with a history of alcohol consumption within 2 weeks; (8) Patients with Helicobacter pylori infection; (9) Patients with allergy to the drug components in this study; (10) Those with imperfect clinical data; (11) Patients who are also participating in other clinical trials.

Study execute time：

From 2022-06-01

To      2023-12-01

Recruiting time：

From 2022-06-01

To      2023-11-30

Interventions：

30

Group：

Joint Group

Sample size：

Intervention：

Combined moxibustion on the basis of the treatment group 1 time / d each time 30 min

Intervention code：

30

Group：

Treatment Group

Sample size：

Intervention：

Treated with Spleen and Stomach Peiyuan Formula, 2 times/d, 1 h after meal

Intervention code：

30

Group：

Control group

Sample size：

Intervention：

Rebapatide tablets combined with folic acid tablets both 1 tablet/dose 3 times/d 1 h before meal.

Intervention code：

Total sample size ： 90

Countries of recruitment
and research settings：

Country：

China

Province：

An Hui

City：

Hefei

Institution/hospital：

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Level of the institution：

grade 3A

Outcomes：

Outcome：

OLGA staging

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

incidence of adverse reactions

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

clinical symptom score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

OLGIM staging

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Endoscopic gastric mucosal pathological tissue score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

PRO scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Pathological gastric mucosal tissue

Tissue：

gastric

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Completed

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomisation into three groups was carried out by a statistician using SPSS (25.0)

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Sheet

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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