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Effect of Valerian and Lemon Balm Combined Capsules, On Postmenopausal Sleep Disorder, a Triple Blind Randomized Placebo Control Clinical Trial

Published online by Cambridge University Press:  15 April 2020

S. Taavoni
Affiliation:
Senior lecturer in Iran University of Medical Sciences (IUMS) PhD Student in Medical Education,, Faculty of Medicine Tehran University of Medical Sciences (TUMS) Research Institute for Islamic and Complementary Medicine (RICM, IUMS)
N.N. Ekbatani
Affiliation:
PhD Student in Medical Education,, Faculty of Medicine Tehran University of Medical Sciences (TUMS)
H. Haghani
Affiliation:
Senior lecturer in Iran University of Medical Sciences (IUMS)

Abstract

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Sleep disorder in menopause women, affect their quality of life and must mange by safe methods.

Objectives

To determine effect of Valerian/Lemon balm combined capsules on Sleep Disorder.

Methods

In this triple blind randomized control clinical trial, 100 volunteer healthy menopause women with aged 50-60 years, who complained of sleep disorders, were selected randomly in clinics of West of Tehran (50 in each group). After filling in informed consent, intervention group received two combined capsules of 160 Mg Valerian and 80 Mg Lemon Balm in a day and control group received 50 Mg Starch as placebo capsules two times in a day for one month. Pittsburg Sleep Quality Index (PSQI) had been used. All ethical points were considered.

Results

The average age of the experimental group was 52.5 ± 7.8 and 53.7 ± 3.5 in the control group with a menopausal onset age of 47.6± 4.1 and 49.1 ± 3/9 respectively. Equality ofdemographic characteristics and PSQI before intervention had been checked in two groups. 36% of the experimental group and 8% of the placebo group showed an improvement in the quality of their sleep and sleep scores have decreased 5 points. (P = 0.0001). There was significant difference in PSQI between groups (p > 0.05)

Conclusion

Findings support use of Valerian and Lemon balm combined capsules in the clinical management of sleep disorder in menopause. No side effects had been seen during study and one month later. It is suggested to continue this study with more duration.

Type
Article: 1784
Copyright
Copyright © European Psychiatric Association 2015
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