Jianzhong Qushi in Chronic RRI

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.

NCT Number	NCT06837597
Lead Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions	Chronic Radiation Proctitis
Enrollment	168 participants
Start Date	2025-03-15
Primary Completion	2028-08-31 (estimated)
Study Completion	2029-01-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-27