Clinical Study of Weifuchun Treatment on Precancerous Lesions of Gastric Cancer

NCT ID: NCT03814629

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2019-09-30

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.

Conditions

Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

precancerous lesions of gastric cancer

120 cases of chronic atrophic gastritis with intestinal metaplasia or dysplasia,It was randomly divided into 60 cases of treatment group and 60 cases of control group,treatment group was given Weifuchun tablets,The control group was given vitamin tablets.

Group Type: OTHER

Weifuchun

Intervention Type: DRUG

The treatment group（Weifuchun group）was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group(vitamin group) was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal.

Interventions

Weifuchun

The treatment group（Weifuchun group）was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group(vitamin group) was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal.

Intervention Type: DRUG

Other Intervention Names

vitamin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ShuGuang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mingyu Sun

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mingyu Sun, doctor

Role: PRINCIPAL_INVESTIGATOR

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

References

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.

Reference Type: DERIVED

PMID: 34801051 (View on PubMed)

Other Identifiers

42507214-9

Identifier Type: -

Identifier Source: org_study_id