The Effect of Valerian on Insomnia in Menopausal Women

Not Applicable

Recruiting

• Conditions: Insomnia; Menopausal Women
• Interventions: Drug: Valerian

• Registration Number: NCT05185219
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study First Submitted: 2021-12-03
• Study Start: 2021-12-14
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Valerian	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
Valerian	Valerian	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Traditional Chinese medicine (TCM) constitution	30 days	TCM constitution will be measured by three TCM doctor and TCM questionnaire

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan