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NOT YET RECRUITING
NCT06837597
PHASE3

Jianzhong Qushi in Chronic RRI

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled trial. Patients diagnosed as CRP and without TCM history will be enrolled and randomly assigned to either the treatment group (receiving standard care plus Jianzhong Qushi Formula, 100 ml bid, \*28days) or the control group (receiving standard care plus placebo 100 ml bid, \*28days). All of the patients received both The primary endpoint is the clinical response rate, defined as fulfilling one of the following, RTOG grade reduction, ① RTOG/EORTC grade reduction; ② ≥1 symptom downgraded by CTCAE v5.0; ③ Symptom improvement according to TCM symptom standards .The secondary endpoints included TCM syndrome score reduction rate, LENT/SOMA score changes, changes in gut microbiota, quality of life(QoL) , etc. Totally, 168 patients (84 in each group) will be enrolled.

Official title: Jianzhong Qushi Formula for Treating Chronic Radiation Induced Proctitis : a Multicenter, Prospective, Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2025-03-15

Completion Date

2029-01-31

Last Updated

2025-02-27

Healthy Volunteers

No

Interventions

DRUG

Jianzhong Qushi Formula

Jianzhong Qushi Formula (A Chinese traditional formula, approved by Chinese Patent, No. ZL202210097886.0)

DRUG

Placebo

A simulated Chinese medicine placebo, with similar appearance and smell to Jianzhong Qushi Formula.