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Jianzhong Qushi in Chronic RRI

NCT06837597 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-02-27

No results posted yet for this study

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.

Conditions

  • Chronic Radiation Proctitis

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.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Li Feng, MD. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2028-08-31
Completion
2029-01-31

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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 NCT06837597 on ClinicalTrials.gov