The Effect of Valerian on Insomnia in Menopausal Women

China Medical University

Status: Enrolling

Conditions: Menopausal Women; Insomnia

Treatments: Drug: Valerian

Study type: Interventional

Funder types: Other

Identifiers

NCT05185219

2021MenoVal / CMUH109-REC2-177

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Valerian

Experimental group

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

Treatment:

Drug: Valerian

Control

Placebo Comparator group

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

Treatment:

Drug: Valerian