Gastric Intestinal Metaplasia
Conditions
Brief summary
The goal of this clinical trial is to investigate the efficacy and safety of Weifuchun tablet in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. The main questions it aims to answer are: Does Weifuchun tablet promote the regression of gastric intestinal metaplasia in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Weifuchun tablet? Researchers will compare the effectiveness of Weifuchun tablet in treating gastric intestinal metaplasia with that of folic acid, as suggested by the Chinese consensus on management of gastric epithelial precancerous conditions and lesions (2020). Participants will: Take Weifuchun tablets or folic acid every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.
Interventions
DRUGWeifuchun
Subjects will be instructed to take four tablets (1400mg) of Weifuchun three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.
DRUGFolic Acid
Subjects will be instructed to take one tablet (5mg) of folic acid three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.
Sponsors
Yongquan Shi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients aged from 18 to 75 years old. * patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months. * patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.
Exclusion criteria
* a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins. * a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor. * a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study. * breastfeeding or pregnancy. * a history of substance abuse or alcohol abuse within the past one year. * patients with severe mental illness. * refusal to undergo drug treatment. * refusal to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. | From enrollment to the end of treatment at 6 months. | Regression was defined as a OLGIM stage decreased at least one grade. |
| The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. | From enrollment to the end of treatment at 6 months. | Progression was defined as a OLGIM stage increased at least one grade. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The regression rate of gastric atrophy based on OLGA stage in different groups. | From enrollment to the end of treatment at 6 months. | Regression was defined as a OLGA stage decreased at least one grade. |
| The progression rate of gastric atrophy based on OLGA stage in different groups. | From enrollment to the end of treatment at 6 months. | Progression was defined as a OLGA stage increased at least one grade. |
Countries
China
Contacts
CONTACTYongquan Shi
Outcome results
None listed