The Effect of Valerian on Insomnia in Menopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Valerian on Insomnia in Menopausal Women: Randomized Placebo-controlled Trial

Conditions
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Menopausal Women, Insomnia

Intervention / Treatment
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* Drug: Valerian


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45〜60 years old, and is menopaused for at least 1 year。 meet the criteria of ICSD-3 for insomnia PSQI > 5 Exclusion Criteria: psychiatry disease Heart, brain, liver diseases Insomnia is caused by diseases. Steroid used within 6 months pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valerian<br>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 | Drug: Valerian<br>* A natural plant<br>|
| Placebo Comparator: Control<br>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 | Drug: Valerian<br>* A natural plant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traditional Chinese medicine (TCM) constitution | TCM constitution will be measured by three TCM doctor and TCM questionnaire | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, insomnia, valerian