A randomized controlled trial on the efficacy and safety of Gegen Qinlian decoction in the treatment of Damp-heat Type colorectal cancer
- Conditions
- Colorectal Cancer
- Registration Number
- ITMCTR2100004460
- Lead Sponsor
- Zhejiang Traditional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. The patients who meet the diagnostic criteria of Colorectal cancer,staged as stage III or IV,and conformed to the standard of syndrome differentiation of damp-heat type in traditional Chinese medicine.
2. Age between 18 to 75 years.
3. Karnofsky performance status (KPS)>= 60,those patients who are expected to survive for more than 3 months from the day of enrollment.
4. No other traditional Chinese medicine, preparations affecting immune function, antibiotics or probiotics were used within 3 weeks.
5. Sign the patient's informed consent.
1. Complicated with serious heart, lung, liver, kidney and other diseases or other serious diseases, including uncontrolled active infection, severe electrolyte disturbance and obvious bleeding tendency, or serious complications (such as active gastrointestinal bleeding, gastrointestinal perforation, obstruction, jaundice);
2. The women who are pregnant or lactating.
3. A history of mental illness such as dementia or epilepsy.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (OS);Progression-free survival (PFS);Contrast-enhanced CT/MRI of the abdomen;Objective Response Rate (ORR);
- Secondary Outcome Measures
Name Time Method