Insomnia, Menopausal Women
Conditions
Keywords
menopause, insomnia, valerian
Brief summary
Menopausal women often complain that it is difficult to fall asleep and easy to wake up at night and early in the morning and it is in the middle of night difficult to fall asleep again. If the above symptoms persist for at least three months and occur at least three times a week, plus the impact on daytime work and rest, and meet the International Classification of Sleep Disorders (ICSD-3) )'S s Insomnia diagnostic criteria. According to statistics, 30% to 60% of women face sleep disorders during menopause.
Detailed description
The investigators expect to receive outpatient admissions in the hospital attached to China Medical University. Menopausal women aged 45-60 years old who have been diagnosed with insomnia who meet criteria of International Classification of Sleep Disorders (ICSD-3) will be randomly assigned for clinical trials. Patients will take two Valerian capsules (1000mg/day) per day for four weeks. Pittsburgh Sleep Index (PSQI) will be used to evaluate subjective sleep quality. TCM patterns will be evaluated by three physicians of TCM gynecology independently before and after taking Valeriana. The data will conduct a biological analysis to compare the difference in sleep quality between the trial group and the control group.
Interventions
DRUGValerian
A natural plant
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. 45〜60 years old, and is menopaused for at least 1 year。 2. meet the criteria of ICSD-3 for insomnia 3. PSQI \> 5
Exclusion criteria
1. psychiatry disease 2. Heart, brain, liver diseases 3. Insomnia is caused by diseases. 4. Steroid used within 6 months 5. pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quallity | 30 days | Sleep quality will be evaluated by Pittsburgh Sleep Index (PSQI). The sum of the scores on PSQI ranges from 0 to 21, and higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Traditional Chinese medicine (TCM) constitution | 30 days | TCM constitution will be measured by three TCM doctor and TCM questionnaire |
Countries
Taiwan
Contacts
Primary ContactShan-Yu Su
Outcome results
None listed