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Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer

NCT05229809 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2022-11-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.

Conditions

  • Gastric Carcinoma

Interventions

DRUG

Yiqi Wenyang Jiedu prescription

The dosage form of the test drug is granule. Patients need to take 2 small packets in the morning and 2 small packets in the evening. The medicine needs to be melted in hot water before being taken. Every 4 weeks is a course of treatment, a total of 6 courses,The patients were followed up to 3 years after gastric cancer surgery.

DRUG

Simulation agent of Yiqi Wenyang Jiedu prescription

It is prepared from maltodextrin and food coloring. The raw materials of maltodextrin conform to the relevant provisions of excipients - maltodextrin in the fourth part of Chinese Pharmacopoeia 2015 edition. Food coloring includes caramel coloring, egg yolk coloring and milk chocolate brown pigment, all of which are edible grade ingredients. Patients need to take 2 small packets in the morning and 2 small packets in the evening. The medicine needs to be melted in hot water before being taken. Every 4 weeks is a course of treatment, a total of 6 courses,The patients were followed up to 3 years after gastric cancer surgery.

Sponsors & Collaborators

  • Jie Li

    lead OTHER

Principal Investigators

  • Jie Li, Professor · Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

  • Yu Wu, Professor · Xiyuan Hospital of China Academy of Chinese Medical Sciences

  • Shijie Zhu, Professor · Wangjing Hospital, China Academy of Chinese Medical Sciences

  • Hong Zhao, Professor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Lizhu Lin, Professor · The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  • Ling Xu, Professor · Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

  • Peng Shu, Professor · Jiangsu Hospital of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-07-31
Completion
2024-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229809 on ClinicalTrials.gov