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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valerian | Experimental | generic name: XIE CAO CONC dosage form: capsule dosage: 500 mg/capsule, 6 capsules a day frequency: 3 times a day after each meal, 2 capsules each time duration: 30 days |
|
| Control | Placebo Comparator | generic name: placebo (Caramel Colors dyed starch) dosage form: capsule dosage: 500 mg/capsule, 6 capsules a day frequency: 3 times a day after each meal, 2 capsules each time duration: 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valerian | Drug | A natural plant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quallity | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Traditional Chinese medicine (TCM) constitution | TCM constitution will be measured by three TCM doctor and TCM questionnaire | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
Female-specific condition
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shan-Yu Su | Contact | 0975682032 | shanyusu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University | Recruiting | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000713890 | Valeriana extract |
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| D001523 |
| Mental Disorders |