NCT05888675

Clinical Study of Weifuchun Treatment on Gastric Cancer

Randomized Clinical Trial:Clinical Study of Weifuchun Treatment on Gastric Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: ShuGuang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the prevention and treatment 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 gastric cancer.

Detailed description

Weifuchun Treatment and mechanism on 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 gastric cancer Therapeutic Schedule#In this study, 72 patients with gastric cancer who received chemotherapy in the Department of Gastrointestinal Surgery and Oncology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were recruited and divided into groups according to random number table method, namely, 36 patients in the Weifichun combined chemotherapy group and 36 patients in the chemotherapy group alone. Weichun group was treated with 24 weeks of Chinese patent medicine Weichun tablet at the same time of chemotherapy. The physical status score, TCM syndrome score, quality of life score, bone marrow suppression and tumor index of the two groups before and 24 weeks after treatment were observed and compared.Fecal samples of the above patients before and after the entry and exit groups were collected, screened and submitted for examination. Finally, 15 cases were submitted for examination in the Weifichun combined chemotherapy group and chemotherapy group alone, and 10 cases were submitted for examination in the healthy volunteers. Miseq platform was used to conduct high-throughput sequencing and analysis of 16S ribosomal RNA of intestinal flora, fecal quality assessment of intestinal flora tested was conducted, α diversity and β diversity were analyzed, and the flora structure, including the level of taxonomy, family, genus, etc., were compared to analyze the differences in each group, and elucidate the possible mechanism of action of Weichun in the treatment of gastric cancer patients.

Conditions

• Gastric Cancer (Diagnosis)

Interventions

Type	Name	Description
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(chemotherapy group)#Chemotherapy regimen was based on the Chinese Clinical Oncology Association Guidelines for the Diagnosis and Treatment of Gastric Cancer (2018), including oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, and Ticeo monotherapy regimen.

Timeline

• Start date: 2016-07-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2023-06-05
• Last updated: 2023-07-25