The Effect of Valerian on Insomnia in Menopausal Women

NCT ID: NCT05185219

Last Updated: 2024-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-14

Study Completion Date

2025-01-20

Brief Summary

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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

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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

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Menopausal Women Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Valerian

Intervention Type DRUG

A natural plant

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

Group Type PLACEBO_COMPARATOR

Valerian

Intervention Type DRUG

A natural plant

Interventions

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Valerian

A natural plant

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shan-Yu Su

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China Medical University

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shan-Yu Su

Role: CONTACT

0975682032

Facility Contacts

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Su Shan-yu

Role: primary

0975682032

Other Identifiers

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2021MenoVal / CMUH109-REC2-177

Identifier Type: -

Identifier Source: org_study_id

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