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The Effect of Valerian on Insomnia in Menopausal Women

Primary Purpose

Menopausal Women, Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Valerian
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopausal Women focused on measuring menopause, insomnia, valerian

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Valerian

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Traditional Chinese medicine (TCM) constitution
TCM constitution will be measured by three TCM doctor and TCM questionnaire

Full Information

First Posted
December 3, 2021
Last Updated
January 7, 2022
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05185219
Brief Title
The Effect of Valerian on Insomnia in Menopausal Women
Official Title
The Effect of Valerian on Insomnia in Menopausal Women: Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopausal Women, Insomnia
Keywords
menopause, insomnia, valerian

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Valerian
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Valerian
Intervention Description
A natural plant
Primary Outcome Measure Information:
Title
Sleep quallity
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Traditional Chinese medicine (TCM) constitution
Description
TCM constitution will be measured by three TCM doctor and TCM questionnaire
Time Frame
30 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female-specific condition
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 45〜60 years old, and is menopaused for at least 1 year。 meet the criteria of ICSD-3 for insomnia PSQI > 5 Exclusion Criteria: psychiatry disease Heart, brain, liver diseases Insomnia is caused by diseases. Steroid used within 6 months pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shan-Yu Su
Phone
0975682032
Email
shanyusu@gmail.com
Facility Information:
Facility Name
China Medical University
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Shan-yu
Phone
0975682032
Email
shanyusu@gmail.com
First Name & Middle Initial & Last Name & Degree
Chen Xin-xi

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Valerian on Insomnia in Menopausal Women

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