Comparative effectiveness study of Cheonwangbosimdan Liquid for Insomnia of Cancer Patients

Not Applicable

Recruiting

Conditions: Mental and behavioral disorders

Registration Number: KCT0002502

Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 22

Inclusion Criteria

• Have a histological and/or radiological diagnosis of cancer (any type and any stage)
• Completion in cancer-related treatments (e.g. surgery, radiotherapy, and chemotherapy) not less 1 month prior to the study enrollment
• The Eastern Cooperative Oncology Group (ECOG) performance status = 2
• Total score in the Insomnia Severity Index = 8 points
• Cintinuous insomnia for at least 1 month

Exclusion Criteria

• Insomnia caused by pain
• Insomnia caused by nausea or vomiting
• Insomnia caused by pleural effusion, ascites, or edema
• Restless legs syndrome
• Sleep apnea syndrome
• Shift workers
• Substance use disorders based on 'The Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM-V)'
• Any psychological disorders in current
• Any type of seizures in the past
• New administration of insomnia-related drug or functional food within 1 week
• Cognitive behavioral therapy for insomnia within 1 month prior to the study enrollment
• AST or ALT = 2 * upper normal limit (UNL)
• Creatinine = 1.5 * UNL
• No willingness to participate in the trial and provide written consent
• Pregnancy, lactation, or planning a pregnancy
• Difficulty complying with the treatment, questionnaire, or study protocol

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean changes of total scores in the insomnia severity index (ISI)

Secondary Outcome Measures

Name	Time	Method
Mean changes of total scores in the Pittsburgh Sleep Quality Index(PSQI);Mean changes of total scores in the Epworth Sleepiness Scale(ESS);Mean changes of total scores in the Zung Self-rating Anxiety Scale(SAS) ;Mean changes of total scores in the Brief Fatigue Inventory (BFI);Mean changes of total scores in the EQ-5D-5L;Quality of sleep measured by activity tracker device;Quality of sleep measured by sleep diary;Adverse event