The Effect of Valerian on Insomnia in Menopausal Women
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2021
CompletedStudy Start
First participant enrolled
December 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2025
CompletedApril 8, 2024
April 1, 2024
3.1 years
December 3, 2021
April 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Traditional Chinese medicine (TCM) constitution
30 days
Study Arms (2)
Valerian
EXPERIMENTALgeneric 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
Control
PLACEBO COMPARATORgeneric 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
Interventions
Eligibility Criteria
You may qualify if:
- 〜60 years old, and is menopaused for at least 1 year。
- meet the criteria of ICSD-3 for insomnia
- PSQI \> 5
You may not qualify if:
- psychiatry disease
- Heart, brain, liver diseases
- Insomnia is caused by diseases.
- Steroid used within 6 months
- pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University
Taichung, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 3, 2021
First Posted
January 11, 2022
Study Start
December 14, 2021
Primary Completion
January 20, 2025
Study Completion
January 20, 2025
Last Updated
April 8, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share