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A Study on the Efficacy Evaluation of an Intervention Approach Combining Regional Scope and Degree for Eliminating Turbidity, Removing Blood Stasis, and Detoxification in Treating High-Risk Atrophic Gastritis

A Study on the Efficacy Evaluation of an Intervention Approach Combining Regional Scope and Degree for Eliminating Turbidity, Removing Blood Stasis, and Detoxification in Treating High-Risk Atrophic Gastritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001847
Enrollment
Unknown
Registered
2025-09-26
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-Risk Atrophic Gastritis

Interventions

treatment group1:Xianglian Huazhuo Granules
control group1:Xianglian Huazhuo Granule Simulator
treatment group2:Jianpi Huayu Jiedu Granules
control group2:Jianpi Huayu Jiedu Granule Simulator

Sponsors

Hebei Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 and 70 years old, regardless of gender. (2) Those who have undergone gastroscopic pathological examination within the past month, and the disease has been diagnosed as atrophic gastritis with intestinal metaplasia through gastroscopic examination and histological examination of gastric mucosal pathological tissues, and whose OLGA or OLGIM stage is stage III or IV (two pathological experts are required to diagnose the patient's pathology, and the patient can be enrolled only after the two experts reach a consensus). (3) The traditional Chinese medicine syndrome type conforms to the diagnosis of turbid - toxin stagnation in the stomach syndrome or stasis in the gastric collaterals syndrome. (4) Those who have undergone the rapid urease test or breath test within the past month and have a negative Hp result; patients with positive Hp do not need to undergo a re - examination of gastroscopy after the bactericidal treatment turns negative, and can be re - enrolled after evaluation. (5) Sign the informed consent and voluntarily participate in the trial.

Exclusion criteria

Exclusion criteria: (1) Individuals with comorbidities of peptic ulcer, gastroesophageal reflux disease, gastric polyps, or hiatal hernia. (2) Those with comorbidities of high - grade intraepithelial neoplasia of the gastric mucosa, suspected malignant transformation of gastrointestinal mucosal lesions, or gastrointestinal tumors. (3) Patients with malignant tumors who have undergone surgery, radiotherapy, or chemotherapy within the past 5 years. (4) Individuals with severe organic diseases that threaten their quality of life and are unable to cooperate with drug treatment, such as heart diseases (NYHA class III - IV cardiac function, hemodynamically unstable myocardial infarction, etc.), liver diseases (decompensated cirrhosis, etc.), kidney diseases (uremic stage of chronic renal failure, etc.), lung diseases (tuberculosis, acute asthma attack, pulmonary infection, etc.), and autoimmune system diseases (active stage of systemic lupus erythematosus). (5) Individuals with allergic constitution, those allergic to multiple drugs, or those allergic to the components of the known test drugs. (6) Patients with severe mental illnesses (such as schizophrenia, anxiety disorder) who are unable to cooperate with the research. (7) Pregnant women, lactating women, and women with fertility requirements. (8) Individuals with a history of alcohol or drug abuse. (9) Those who have participated in other drug clinical trials within 4 weeks before enrollment.

Design outcomes

Primary

MeasureTime frame
Effective rate of pathological improvement in gastric mucosal tissue;

Secondary

MeasureTime frame
Evaluation of the microscopic state of the gastric mucosa;Clinical symptom score;

Countries

China

Contacts

Public ContactYang Qian

Hebei Provincial Hospital of Chinese Medicine

yang0311qian@126.com13832355120

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026