This study was designed to evaluate the beneficial effects and safety of a standardised botanical extract combination containing soy isoflavone extract, grains of paradise seed dry extract and pomegranate skin dry extract on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the self reported and validated Cervantes Scale.
Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
57
Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)
Filler agent
Clinica Barem
Las Palmas de Gran Canaria, Las Palmas (Canary Islands), Spain
Change from Baseline to Week 8 in the global score of quality of life using the validated Cervantes Scale
To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for global score (GS) in quality of life is generated: \[Variation%=100 x ((initial GS value-final GS value)/ initial GS value)\]
Time frame: 8 weeks
Change from Baseline to Week 8 in the Menopause-health score of quality of life using the validated Cervantes Scale
To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for Menopause and health score (MHS) in quality of life is generated: \[Variation%=100 x ((initial MHS value-final MHS value)/ initial MHS value)\]
Time frame: 8 weeks
Change from Baseline to Week 8 in the psychic score of quality of life using the validated Cervantes Scale
To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for psychic score (PS) in quality of life is generated: \[Variation%=100 x ((initial PS value-final PS value)/ initial PS value)\]
Time frame: 8 weeks
Change from Baseline to Week 8 in the sexuality-couple score of quality of life using the validated Cervantes Scale.
To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for sexuality-couple score (SCS) in quality of life is generated: \[Variation%=100 x ((initial SCS value-final SCS value)/ initial SCS value)\]
Time frame: 8 weeks
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