Effect of valerian root extract on sleep disturbances in menopausal women referred to selected health centers affiliated to Iran University of Medical Sciences 1388

Phase 1

Conditions: Sleep disorders.
Nonorganic sleep disorders
F51.0, F51

Registration Number: IRCT138903252172N4

Lead Sponsor: Vice chancellor for reasearch, Iran University of Medical Sciences

Brief Summary: Abstract OBJECTIVE: Sleep disturbances reduce the quality of life. About 50% of postmenopausal women experience sleep disturbances such as insomnia. Complementary and alternative medical therapies may be useful for the management of sleep disturbances among postmenopausal women. The aim of the present study was to evaluate the effects of valerian extract taken nightly on the improvement of sleep quality in postmenopausal women experiencing insomnia. METHODS: A randomized, triple-blind, controlled trial design was used for this study. Participants consisted of 100 postmenopausal women aged 50 to 60 years who were experiencing insomnia. A demographic data form and the Pittsburgh Sleep Quality Index were used to collect data. The women were randomly divided into two groups. Each group received either 530 mg of concentrated valerian extract or a placebo twice a day for 4 weeks. Descriptive and inferential statistics were used to analyze the data. RESULTS: A statistically significant change was reported in the quality of sleep of the intervention group in comparison with the placebo group (P < 0.001). Also, 30% of the participants in the intervention group and 4% in the placebo group showed an improvement in the quality of sleep (P < 0.001). CONCLUSIONS: Valerian improves the quality of sleep in women with menopause who are experiencing insomnia. Findings from this study add support to the reported effectiveness of valerian in the clinical management of insomnia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 100

Inclusion Criteria

Inclusion and Exclusion criteria:
• Not having physical and psychological diseases which may cause sleep problems
• Not to use tobacco, drugs and alcohol
• Appearance of any physical illness and psychological disorder while in study
• Significant change in sleep conditions such as travel, shift work, etc.
• Taking any additional medication during the study
• Not taking the drug under investigation for more than 7 days during the study

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep dysfunction score. Timepoint: Before intervention and one month after intervention. Method of measurement: Pittsburg Sleep Quality Index questionnaire.

Secondary Outcome Measures