ITMCTR2024000213
Completed
Early Phase 1
Clinical efficacy of spleen spleen in treatment of sleep disorders associated with malignant tumor
Shanghai Traditional Chinese Medicine Hospital0 sitesTBD
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shanghai Traditional Chinese Medicine Hospital
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Diagnosis as malignant tumor meets the above diagnostic criteria;
- •2\)Meet the diagnostic criteria for tumor\-related sleep disorders;
- •3\) In line with the TCM spleen deficiency syndrome
- •4\) Age is 18 years old, and gender is unlimited;
- •5\)Patients with an estimated survival period of 6 months, physical strength status scoring criteria (ECOG) 2;
- •6\)Consent to receive the follow\-up visit;
- •7\)Complete follow\-up and clinical relevant medical records;
- •8\)To voluntarily sign the informed consent form.
Exclusion Criteria
- •1\)Patients with severe heart, brain, liver and kidney diseases, electrolyte abnormalities or mental illness;
- •2\) Allto drugs or ingredients used in the study;
- •3\)Pregnancy, lactation, or planned pregnancy patients;
- •4\) presence of severe or uncontrollable infection;
- •5\)Those who took other Chinese medicine or participated in other clinical trials.
Outcomes
Primary Outcomes
Not specified
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