Comparative effectiveness study of Cheonwangbosimdan Liquid for Insomnia of Cancer Patients

Comparative Effectiveness of Cheonwangbosimdan Liquid Administration versus Cognitive-Behavioral Therapy for Insomnia of Cancer Patients: A Randomized, Parallel-group, Pilot trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002502

Enrollment

Registered

2017-10-19

Start date

2017-07-12

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Subjects are randomly assigned to one of the two groups: Cheonwangbosimdan Liquid administration group (Treatment group), Cognitive behavioral therapy for insomnia group (Control group). The tr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Mean changes of total scores in the insomnia severity index (ISI)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Korea, Republic of

Contacts

Public ContactJee Young Lee

Kyung Hee University Oriental Medicine Hospital at Gangdong

happiade@daum.net+82-2-440-8274

Outcome results