Fuzheng Nizeng Formula for treating chronic atrophic gastritis with low-grade intraepithelial neoplasia
Fuzhegn Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial
This study is testing a new herbal treatment called Fuzheng Nizeng Formula to see if it can help people with chronic atrophic gastritis and low-grade cell changes in their stomach feel better compared to a standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06324825 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of the Fuzheng Nizeng Formula (FZNZ), derived from the classic Liujunzi Decoction, in treating chronic atrophic gastritis with low-grade intraepithelial neoplasia. The study compares the effects of FZNZ against a positive control, Moluodan granules, to determine its effectiveness in promoting recovery from gastric atrophy and alleviating related symptoms. Participants will be diagnosed through endoscopy and stomach biopsy, and the trial will focus on those who are Helicobacter pylori negative and exhibit specific Traditional Chinese Medicine syndromes.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with chronic atrophic gastritis with low-grade intraepithelial neoplasia who are Helicobacter pylori negative.
Not a fit: Patients with a history of gastric surgery, malignant tumors, mental illness, or allergies to the study drugs will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from chronic atrophic gastritis with low-grade intraepithelial neoplasia.
How similar studies have performed: While there have been pilot studies indicating potential benefits of FZNZ, this specific approach is relatively novel and has not been extensively tested in larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia diagnosed by endoscopy and stomach biopsy. * Helicobacter pylori negative. * TCM syndrome is spleen-stomach deficiency with blood stasis and phelgm. Exclusion Criteria: * History of gastric surgery. * Combined with malignant tumor. * History of mental illness. * Allergy to any components of the drug use in the study. * Planning to pregnancy, or pregnant woman and lactating woman.
Where this trial is running
Beijing, Beijing
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.