Clinical Study of Weifuchun Treatment on Precancerous Lesions of Gastric Cancer

NCT03814629 | Unknown Early Phase 1

• 1 other identifier: 42507214-9
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)

Keywords

chronic atrophic gastritis; precancerous lesions of gastric cancer; Weifuchun; randomized clinical trial; mechanism

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• blood routine examination

  the patients' were included into the clinical trials and after 24 weeks treatment

• liver function test

  the patients' were included into the clinical trials and after 24 weeks treatment

• kidney function test

  the patients' were included into the clinical trials and after 24 weeks treatment

Study Arms (1)

precancerous lesions of gastric cancer

OTHER

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

Interventions

Weifuchun 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.

Also known as: vitamin

precancerous lesions of gastric cancer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ShuGuang Hospital: lead

Related Publications (1)

• 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.

  PMID: 34801051 DERIVED

MeSH Terms

Conditions

Disease; Gastritis, Atrophic

Interventions

weifuchun; Vitamins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mingyu Sun, doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: January 24, 2019
• Study Start: August 1, 2015
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 24, 2019

Record last verified: 2019-01