Clinical trial NCT03814629: Clinical Study of Weifuchun Treatment on Precancerous Lesions of Gastric Cancer
Official title: Randomized Clinical Trial: Weifuchun Treatment on Precancerous Lesions of Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)
Keywords: chronic atrophic gastritis
precancerous lesions of gastric cancer
Weifuchun
randomized clinical trial
mechanism
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the prevention and treatment of chronic atrophic gastritis and precancerous lesions of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape and other possible aspects to elucidate the effective and mechanism of weifuchun's treatment on chronic atrophic gastritis, reversing precancerous lesions of gastric cancer.

Detailed description: Clinical research abstract Title of Research Study：Randomized clinical trial: Weifuchun Treatment and mechanism on Precancerous Lesions of Gastric Cancer.

Main Responsibility Person: Mingyu Sun research center：Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Trial Objective：Observe the clinical efficacy and mechanism of Weifuchun in the treatment of chronic atrophic gastritis (CAG) and precancerous lesions of gastric cancer (PLGC) Therapeutic Schedule：Select 60 cases of chronic atrophic gastritis with intestinal metaplasia or dysplasia from and 60 cases of chronic atrophic gastritis without intestinal metaplasia or dysplasia at the Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. The treatment group was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal. The course of chronic atrophic gastritis with intestinal metaplasia or dysplasia group treatment is 24 weeks, the course of chronic atrophic gastritis without intestinal metaplasia or dysplasia is 12 weeks. The all patients'clinical symptoms, histopathology, gastroscopy, and physical and chemical examinations were compared between the two groups before and after treatment.

Eligibility criteria: Inclusion Criteria:

1. Patients with chronic atrophic gastritis and precancerous lesions according to the pathological findings under gastroscope
2. Helicobacter pylori(-)

Exclusion Criteria:

1. Patients with Helicobacter pylori positive infection without radical treatment.
2. Patients with peptic ulcer, severe dysplasia or suspected malignant transformation.
3. Pregnant or lactating women and those who are pregnant and may not have effective contraception.
4. Patients with severe heart, lung, gallbladder, kidney, endocrine, hematopoietic system and neuropsychiatric diseases should not be included in this study.
5. Allergic constitution or known ingredients of this medicine.
6. Patients with other tumors.
7. Patients participating in other clinical trials within 1 month.
8. Patients with severe cirrhotic ascites and portal hypertension.
9. Other diseases that interfered with the study were deemed unsuitable for the patients included in the study.

Primary outcomes:
measure: histopathology is assessing a change
timeFrame: the patients' were included into the clinical trials and after 24 weeks treatment.
measure: gastroscopy is assessing a change
timeFrame: the patients' were included into the clinical trials and after 24 weeks treatment.
measure: Clinical symptom score is assessing a change
timeFrame: the patients' were included into the clinical trials and after 24 weeks treatment.
Secondary outcomes:
measure: blood routine examination
timeFrame: the patients' were included into the clinical trials and after 24 weeks treatment
measure: liver function test
timeFrame: the patients' were included into the clinical trials and after 24 weeks treatment
measure: kidney function test
timeFrame: the patients' were included into the clinical trials and after 24 weeks treatment
Other outcomes:
Locations:
Study officials:
affiliation: Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
name: Mingyu Sun, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bian Y, Chen X, Cao H, Xie D, Zhu M, Yuan N, Lu L, Lu B, Wu C, Bahaji Azami NL, Wang Z, Wang H, Zhang Y, Li K, Ye G, Sun M. A correlational study of Weifuchun and its clinical effect on intestinal flora in precancerous lesions of gastric cancer. Chin Med. 2021 Nov 20;16(1):120. doi: 10.1186/s13020-021-00529-9.