Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine
NCT ID: NCT04988165
Last Updated: 2021-08-11
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
PHASE2
30 participants
INTERVENTIONAL
2021-10-08
2022-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment arm
Traditional Chinese Medicine
It is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy.
Interventions
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Traditional Chinese Medicine
It is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy.
Eligibility Criteria
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Inclusion Criteria
1. Planned administration of pyrotinib ≥ 21 days;
2. Grade 1-3 diarrhea after taking pyrotinib, and it is planned to continue taking pyrotinib;
2\. Age ≥ 18 years old;
3\. ECOG PS 0-2；
4\. Life expectancy ≥ 6 months;
5\. Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up
Exclusion Criteria
1. Those who may be allergic to pyrotinib or excipients;
2. It has many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc;
3. Patients with biliary obstruction;
4. Participate in other diarrhea related clinical trials;
5. Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptives during the whole test period;
6. according to the researchers' judgment, there are serious diseases that endanger the safety of patients, or affect the patients to complete the study (including, but not limited to, severe hypertension and severe diabetes, which can not be controlled by drugs).
7. Any other circumstances in which the investigator believes that the patient is not suitable to participate in this study.
18 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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zhongsheng tong, doctor
Role: STUDY_DIRECTOR
Tianjin Medical University Cancer Institute and Hospital
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 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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TCM-padia001
Identifier Type: -
Identifier Source: org_study_id
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