The Effect of Valerian on Insomnia in Menopausal Women

• Sponsor: China Medical University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05185219
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.5
• Patients Per Site Per Month: 10.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Menopausal Women; Insomnia	Drug: Valerian	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Valerian on Insomnia in Menopausal Women: Randomized Placebo-controlled Trial
• Actual Study Start Date: Dec 14, 2021
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sleep quallity [30 days]

   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

1. Traditional Chinese medicine (TCM) constitution [30 days]

   TCM constitution will be measured by three TCM doctor and TCM questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University	Taichung		Taiwan

Sponsors and Collaborators

• China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shan-Yu Su, Director, China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT05185219
• Other Study ID Numbers: 2021MenoVal / CMUH109-REC2-177
• First Posted: Jan 11, 2022
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shan-Yu Su, Director, China Medical University Hospital: menopause; insomnia; valerian
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jan 11, 2022