Jianzhong Qushi in Chronic RRI (NCT06837597) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Jianzhong Qushi in Chronic RRI
168 participantsStarted 2025-03-15
Plain-language 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, ①RTOG/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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 - 85 years old
* ECOG score ≤ 2
* Pathologically confirmed malignant tumor
* Received pelvic radiotherapy, and it has been ≥ 3 months since the end of radiotherapy ;
* Meet the diagnostic criteria for chronic radiation proctitis in the "2023 Edition of the Practice Guidelines for the Prevention and Treatment of Radiation Proctitis" or the "2023 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Intestinal Injury in Traditional Chinese and Western Medicine in China", with an international grading of level 1 - 2
* Meet the syndrome of spleen deficiency , and the syndrome differentiation is determined according to the "2017 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Proctitis (Intestinal Syndrome) in Traditional Chinese Medicine" formulated by the Oncology Branch of the China Association of Traditional Chinese Medicine : Basic Syndrome PRO Scale of Spleen Deficiency (meeting 2 main symptoms or 1 main symptom\* + 2 secondary symptoms#).
* Hemoglobin ≥ 100 g / L, neutrophils ≥ 1.5 × 10\^9\^ / L
* Serum creatinine ≤ 1.25 times the upper normal limit (UNL)
* Total bilirubin ≤ 1.5 times UNL, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times UNL
* The patient has signed the informed consent form
* The patient agrees to cooperate with the follow - up. \*Main symptoms included abdominal distension ,anorexia,tenesmus, unsatisfactory bowel movement and fatigue.
* Secondary symptoms…
What they're measuring
1
Response rate
Timeframe: 1-month, 3-month, 6-month
Trial details
NCT IDNCT06837597
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences