Efficacy and Safety of Gamiguibi-tang on Sleep Disturbance of Cancer Patients

Efficacy and Safety of Gamiguibi-tang on Sleep Disturbance of Cancer Patients: a Prospective, Randomized, Wait-list Controlled, Pilot Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001952

Enrollment

Registered

2016-06-24

Start date

2016-03-07

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 : gamiguibi-tang, 3.75g, is orally administered to Arm 1 for three times a day, for 14 days, whereas Arm 2 has no intervention for 14 days. Both arms should take sleep hygiene education at the st

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Insomnia Severity Index	—

Secondary

Measure	Time frame
Beck Depression Inventory;Montreal Cognitive Assessment;Brief Fatigue Inventory	—

Countries

Korea, Republic of

Contacts

Public ContactJee Young Lee

Kyung Hee University Oriental Medicine Hospital at Gangdong

happiade@daum.net

Outcome results