Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer
NCT ID: NCT05187481
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2021-11-15
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental Group
The experimental group will take Jianpi Huatan dispensing granule while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Jianpi Huatan dispensing granule
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Control Group
The experimental group will take Placebo granule (containing 1/10 of the formula dose of Jianpi Huatan Granule) while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Placebo granule
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Interventions
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Jianpi Huatan dispensing granule
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Placebo granule
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Eligibility Criteria
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Inclusion Criteria
2. TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
3. Expected survival time is over 3 months.
4. The age of 18 years old or more.
5. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
6. Chemotherapy and/or targeted therapy are planned.
7. Signed informed consent.
Exclusion Criteria
2. Combined with severe heart, liver, lung and kidney disease.
3. Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
4. Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
5. The expected survival time is less than 3 months.
6. The researchers determine that they were not suitable for the study.
18 Years
ALL
No
Sponsors
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China Academy of Chinese Medical Sciences
OTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Yu Wu, Master
Role: STUDY_CHAIR
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Locations
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Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CI2021A01803
Identifier Type: -
Identifier Source: org_study_id
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