A pilot study of the influence of herbal tea (HT002) on sleep disturbance
- Conditions
- Not Applicable
- Registration Number
- KCT0001900
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 40
? Men and women Less than 45 years old over 35 years old.
? Person who complained of sleep problems more than three times a week such as awakening at least 30 minutes until sleep, awakening at least 30 minutes until resleep after awake.
? Person who got Insomnia Severity Index(ISI) score more than 8point and less than 21 point.
? The one who got least 14 points in the Mibyeong questionnaire.
? Person with a certain profession
? Person who received medical or korean medical treatment for sleep problems in recent one month.
? Person who is taking medication or receiving treatment for nervous system and psychiatric disorders in recent one month.(Depression, anxiety disorders, dementia etc.)
? Person who diagnosed with other diseases which can lead toinsomnia(Sleep apnea, narcolepsy, restless leg syndrome etc.)
? Person who was recently alcohol abuse / dependence within 6 months
? Person who have night work, shift work. and severe duplication.
? Person who don't complain the sleep problem in Mibyeong questionnaire
? Pregnant women, nursing mothers and people who are planning pregnancy within 6 months.
? Person who is taking medication that may affect the clinical studies, or clinical personnel has determined not appropriate person.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of Insomnia Severity Index(ISI) score
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index(PSQI), Mibyeong, demonstration, Short Form-12, Depression, Pulse wave, Heart rate variability, Body Composition, condition of Complexion and tongue, and blood test