NCT05185219

The Effect of Valerian on Insomnia in Menopausal Women

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menopausal Women
• Insomnia

Interventions

Type	Name	Description
DRUG	Valerian	A natural plant

Timeline

• Start date: 2021-12-14
• Primary completion: 2025-01-20
• Completion: 2025-01-20
• First posted: 2022-01-11
• Last updated: 2024-04-08

Locations

1 site across 1 country: Taiwan