The Effect of Valerian on Insomnia in Menopausal Women

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05185219
• Other study ID #: 2021MenoVal / CMUH109-REC2-177
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: January 20, 2025

Study information

• Verified date: April 2024
• Source: China Medical University Hospital
• Contact: Shan-Yu Su
• Phone: 0975682032
• Email: shanyusu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 20, 2025
• Est. primary completion date: January 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Menopausal Women
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Valerian
A natural plant

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Traditional Chinese medicine (TCM) constitution	TCM constitution will be measured by three TCM doctor and TCM questionnaire	30 days