Efficacy and Safety of Gamiguibi-tang on Sleep Disturbance of Cancer Patients
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0001952
- Lead Sponsor
- Comprehensive & Integrative Medicine Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1) over 18.
2) confirmed malignancy by biopsy or radioimage.
3) more than 6 score of Pittsburgh Sleep Quality Index-Korean validation (PSQI-K)
4) more than 2 months of life expectancy
5) cancer or cancer related treatment induced or worsened sleep disturbance.
6) ECOG 0-2
7) sleep disorder lasted for more than recent 1 month.
1) to administrate other korean medicine medications for sleep disorder before the study.
2) having change in hypnotics or psychotropic drugs within 2 weaks before the study.
3) =2×UNL of AST or ALT.
4) sleep apnea or mental illness
5) not consent to the trial protocol
6) women of pregnant, on lactating, or having plan of pregnancy while the process of the trial.
7) expected failed compliance due to any other reasons.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia Severity Index
- Secondary Outcome Measures
Name Time Method Beck Depression Inventory;Montreal Cognitive Assessment;Brief Fatigue Inventory