The Effect of Valerian on Insomnia in Menopausal Women

Last updated: April 5, 2024
Sponsor: China Medical University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Valerian

Clinical Study ID

NCT05185219
2021MenoVal / CMUH109-REC2-177
  • Ages 45-60
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Valerian
Phase:
Study Start date:
December 14, 2021
Estimated Completion Date:
January 20, 2025

Study 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.

Connect with a study center

  • China Medical University

    Taichung,
    Taiwan

    Active - Recruiting

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