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New treatment option for Xiao Chai Hu Tang
Official title XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)
ClinicalTrials.gov ID: NCT06055179
What this study is testing
What is Xiao Chai Hu Tang (XCHT)?
Xiao Chai Hu Tang (XCHT) is an investigational medicine, being studied as a potential treatment for xiao chai hu tang.
Also referred to as Xiao Chai Hu Tang granules from Nin Jiom Medicine Manufactory (Hong Kong) Ltd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Randomized double-blind placebo-controlled trial (RCT) study, to determine the impact of XCHT on irinotecan-induced severe delayed-onset diarrhea (SDOD), and to determine the feasibility of using plasma raloxifene-4'-glucuronide as a probe for intestinal UGT activity.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Malignant tumor confirmed by histology or cytology;
- Age ≥ 18 years old, ≤ 75 years old;
- ECOG score of the patient ≤ 2 points;
- Patients who have diarrhea worse than grade 2 due to irinotecan chemotherapy (the last dose of irinotecan is administered within 1 month);
- Patients who plan to receive 3 cycles of irinotecan chemotherapy (the dose of irinotecan ≥ 125mg/m2);
You likely can't join if
- Patients with diagnosed depression, obsession or/and schizophrenia;
- Patients with diagnosed inflammatory bowel diseases (including Crohn's disease, ulcerative colitis)
- Patient with active tuberculosis and other uncontrolled infections;
- Patient who has previously received radiotherapy on the abdominal cavity or pelvic cavity;
- Pregnant or lactating women;
- Patient who previously had or is now having thromboembolic events.
See the full eligibility criteria
- Malignant tumor confirmed by histology or cytology;
- Age ≥ 18 years old, ≤ 75 years old;
- ECOG score of the patient ≤ 2 points;
- Patients who have diarrhea worse than grade 2 due to irinotecan chemotherapy (the last dose of irinotecan is administered within 1 month);
- Patients who plan to receive 3 cycles of irinotecan chemotherapy (the dose of irinotecan ≥ 125mg/m2);
- Normal organ functions which can meet the requirements for systemic chemotherapy:
- Normal bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×109/L, PLT ≥ 100×109/L, hemoglobin ≥ 90g/L;
- Normal renal functions: serum creatinine ≤ 1.5mg/dl (133μmol/L) and/or creatinine clearance ≥ 60ml/min;
- Normal hepatic functions: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value (ULN), serum aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) ≤ 2.5× ULN; AST \& ALT ≤ 5 × ULN if...
- Patients who can understand and complete the questionnaires in the case report form;
- Patients who can understand and sign the informed consent form, is well compliant, and can be followed up.
- Patients with diagnosed depression, obsession or/and schizophrenia;
- Patients with diagnosed inflammatory bowel diseases (including Crohn's disease, ulcerative colitis)
- Patient with active tuberculosis and other uncontrolled infections;
- Patient who has previously received radiotherapy on the abdominal cavity or pelvic cavity;
- Pregnant or lactating women;
- Patient who previously had or is now having thromboembolic events.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.