Atrophic Gastritis With Low-grade Intraepithelial Neoplasia
Conditions
Keywords
Atrophic Gastritis, Intraepithelial Neoplasia
Brief summary
Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule.
Interventions
DRUGFuzhegn Nizeng Decoction
Subjects taking prepared Fuzhegn Nizeng granules twice daily for 6 month.
DRUGMoluodan granules
Subjects taking prepared Moluodan granules 9g twice daily for 6 month.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery rate of Low-grade Intraepithelial Neoplasia | The 180 days after drug administration. | Stomach biopsy will be taken after drug administration completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-point Global Overall Symptom Scale | 1st, 2nd, 3rd, 4th, 5th, 6th month | Dyspepsia symptoms will be recorded and evaluated by 7-point Global Overall Symptom Scale |
| Adverse event rate | The 6 months during the drug administration | Any adverse event will be recorded. |
Countries
China
Outcome results
None listed