Jianzhong Qushi in Chronic RRI
ConditionChronic Radiation Proctitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
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.
Eligibility criteria
Qualifiers
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 ;
Disqualifiers
Other causes of enteritis cannot be ruled out
The relevant symptoms existed before radiotherapy and did not worsen after treatment
Allergy to more than 3 components of the Western medicine used in this study or the formula of Jianzhong Qushi Formula
Tumor progression requiring urgent anti-tumor treatment
Trial design
Treatments tested in this trial
- Jianzhong Qushi Formula
- Placebo
Treatment groups
168 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov