Clinical Study of Weifuchun Treatment on Precancerous Lesions of Gastric Cancer

Randomized Clinical Trial: Weifuchun Treatment on Precancerous Lesions of Gastric Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)
• Intervention / Treatment: Drug: Weifuchun

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: 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.; Other Names: vitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
histopathology is assessing a change	The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.We use Total score of gastric mucosa pathology to assess the therapeutic effect,the patients' were included into the clinical trials and after 24 weeks treatment we through the Pathological classification of chronic atrophic gastritis work out Total score of gastric mucosa pathology. As follows: There are five pathology grade:Chronic inflammation,Active,Atrophy,intestinal metaplasia,dysplasia. Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 15, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.	the patients' were included into the clinical trials and after 24 weeks treatment.
gastroscopy is assessing a change	The all patients' gastroscopy gastric mucosa manifestations evaluation will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' gastroscopy gastric mucosa manifestations should be evaluated for comparison between two groups, at the same time patients' gastroscopy should be evaluated for comparison in each group. We use Gastric mucosa classification under gastroscope of chronic atrophic gastritis to assess the therapeutic effect,work out gastroscopy gastric mucosa manifestations integral. There are four Gastric mucosa classification under gastroscope of chronic atrophic gastritis: erythema,erosion,Intramucosal hemorrhage,bile regurgitation.Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 12, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.	the patients' were included into the clinical trials and after 24 weeks treatment.
Clinical symptom score is assessing a change	The all patients Clinical symptom assessment score when the patients' were included into the clinical trials and after 24 weeks treatment in each group. We use Clinical Symptom checklist to assess the therapeutic effect,work out Clinical Symptom integral. Clinical symptom mainly includes stomachache, acid reflux, burping, easy to hungry. Score 0 is frequency never;1 is occasionally; 2 is sometimes;3 is often; 4 is always. Summed highest score is 16, summed lowest score is 0.The higher summed score, the more severe the Clinical symptom.	the patients' were included into the clinical trials and after 24 weeks treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood routine examination	The all patients ' blood routine examination(WBC,Hb,PLT) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal blood routine examination(WBC,Hb,PLT) in each group.	the patients' were included into the clinical trials and after 24 weeks treatment
liver function test	The all patients ' liver function test(ALT,Aspartate aminotransferase ,ALP) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal liver function test(ALT,Aspartate aminotransferase ,ALP) in each group.	the patients' were included into the clinical trials and after 24 weeks treatment
kidney function test	The all patients ' kidney function test(Cr,BUN) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal kidney function test(Cr,BUN) in each group.	the patients' were included into the clinical trials and after 24 weeks treatment

Collaborators and Investigators

• Sponsor: ShuGuang Hospital
• Investigators: Principal Investigator: Mingyu Sun, doctor, Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: randomized clinical trial; mechanism; chronic atrophic gastritis; precancerous lesions of gastric cancer; Weifuchun
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Stomach Neoplasms; Gastritis; Hyperplasia; Atrophy; Gastritis, Atrophic; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: 42507214-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No