The Effect of Valerian on Insomnia in Menopausal Women

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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Menopausal Women
• Intervention / Treatment: Drug: Valerian

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shan-Yu Su; Phone Number: 0975682032; Email: shanyusu@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • China Medical University
    • Contact: Su Shan-yu; Phone Number: 0975682032; Email: shanyusu@gmail.com
    • Sub-Investigator: Chen Xin-xi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Valerian; A natural plant
Placebo Comparator: Control; 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; A natural plant

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Estimated): January 20, 2025
• Study Completion (Estimated): January 20, 2025

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: menopause; insomnia; valerian
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2021MenoVal / CMUH109-REC2-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No