Gastric Intestinal MetaplasiaPhase 4NCT06610266
Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia
A Phase 4 study testing Weifuchun and Folic Acid in people with Gastric Intestinal Metaplasia, run by Yongquan Shi at 9 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Intestinal Metaplasia
- What is being tested?
- Weifuchun and Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 9 sitesChina
- Study dates
- 28 Feb 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Ankang Central Hospital
Ankang
Changxin Luo, 15319827011, 871396781@qq.com
- Recruiting
Tongchuan People's Hospital
Tongchuan
Jian Wang, 18992981529, jianyang613@126.com
- Recruiting
Weinan Central Hospital
Weinan
Yali Lei, 0913_2168848, Leiyl8899@163.com
- Recruiting
The 986th Hospital of Air Force Medical University
Xi'an, 710032
Jun Wang, 13669252896, wangjundoctor@aliyun.com
- Recruiting
Xijing hospital
Xi'an, 710032
Yongquan Shi Shi, 029-84771515, shiyquan@fmmu.edu.cn
shiyquan@fmmu.edu.cn
- Recruiting
Xi'an Central Hospital
Xi'an
Baihe Sun, 15129037342, 462731298@qq.com
- Recruiting
Xi'an Honghui Hospital
Xi'an
Shuang Han, 18149296115, shuanghamy@163.com
- Recruiting
Xunyang People's Hospital
Xuchang
Jiang Zan, 13098038886, 107431446@qq.com
- Recruiting
Affiliated Hospital of Yan'an University
Yanan
Pengfei Liu, 15319581618, 464027645@qq.com
About this study
Official title: Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia: A Multi-center, Open-label, Randomized Controlled Trial
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.
- Conditions
- Gastric Intestinal Metaplasia
- Being tested
- Weifuchun, Folic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeifuchunDrug
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.
Folic AcidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| The Weifuchun tablet group | Experimental | Patients in the Weifuchun tablet group will receive oral Weifuchun tablet at a dosage of 1400 mg three times daily for 6 months. Receives: Drug: Weifuchun |
| The folic acid group | Active comparator | Patients in the folic acid group will receive oral folic acid at a dosage of 5 mg three times daily for 6 months. Receives: Drug: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
Regression was defined as a OLGIM stage decreased at least one grade.
Measured: From enrollment to the end of treatment at 6 months.
The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
Progression was defined as a OLGIM stage increased at least one grade.
Measured: From enrollment to the end of treatment at 6 months.
Secondary outcomes (2)
The regression rate of gastric atrophy based on OLGA stage in different groups.
Regression was defined as a OLGA stage decreased at least one grade.
Measured: From enrollment to the end of treatment at 6 months.
The progression rate of gastric atrophy based on OLGA stage in different groups.
Progression was defined as a OLGA stage increased at least one grade.
Measured: From enrollment to the end of treatment at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start28 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Intestinal MetaplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongquan Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610266
- Sponsor's protocol ID
- KY20242224-F-1
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia: A Multi-center, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06610266
- Acronym / sponsor ID
- KY20242224-F-1
- Conditions
- Gastric Intestinal Metaplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yongquan ShiUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Weifuchun tablet group | Experimental | Drug: WeifuchunPatients in the Weifuchun tablet group will receive oral Weifuchun tablet at a dosage of 1400 mg three times daily for 6 months. |
| The folic acid group | Active comparator | Drug: Folic AcidPatients in the folic acid group will receive oral folic acid at a dosage of 5 mg three times daily for 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeifuchunSubjects 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 | The Weifuchun tablet group |
| Folic AcidSubjects 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. | Drug | The folic acid group |
Primary outcome
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.
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.
Time frame: From enrollment to the end of treatment at 6 months.
Progression was defined as a OLGIM stage increased at least one grade.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Weifuchun and Folic Acid in people with Gastric Intestinal Metaplasia, run by Yongquan Shi at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongquan Shi (0086 + 02984771515, shiyquan@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.