Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Weifuchun, Folic Acid.
- Who it may be relevant to
- Registry conditions: Gastric Intestinal Metaplasia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia: A Multi-center, Open-label, Randomized Controlled Trial
Overview
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
- Drug Weifuchun
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. - Drug Folic 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.
Primary outcome measures
- The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. [Time frame: From enrollment to the end of treatment at 6 months.]
- The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. [Time frame: From enrollment to the end of treatment at 6 months.]
Secondary outcome measures (2)
- The regression rate of gastric atrophy based on OLGA stage in different groups. [Time frame: From enrollment to the end of treatment at 6 months.]
- The progression rate of gastric atrophy based on OLGA stage in different groups. [Time frame: From enrollment to the end of treatment at 6 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 9 centers
- Ankang Central Hospital — Ankang
- Tongchuan People's Hospital — Tongchuan
- Weinan Central Hospital — Weinan
- The 986th Hospital of Air Force Medical University — Xi'an
- Xijing hospital — Xi'an
- Xi'an Central Hospital — Xi'an
- Xi'an Honghui Hospital — Xi'an
- Xunyang People's Hospital — Xuchang
- … and 1 more center
Identifiers
NCT: NCT06610266 · KY20242224-F-1