Effects of a New Botanical Extracts Combination on Quality of Life in Menopausal Spanish Women

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Study on the Effect of a Nutritional Supplement With Isoflavones on the Symptoms of Climacteric in Healthy Women

Conditions
-----------------
Menopause, Dietary Supplements, Quality of Life

Intervention / Treatment
-----------------
* Dietary Supplement: Botanical dry extracts combination
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in the Climacteric Phase under medical criteria based on Health questionnaire, Blood and urine test. Informed consent to participate in the study. Exclusion Criteria: Hormone-related pathologies. Menopause from surgery origin. Family or personal history of endocrine cancer. Known hypersensitivity to gluten, soybeans, soy protein, dairy products, pomegranate or grains of paradise. Vegetarian diet or daily consumption of soya rich-products during the last year. Anovulatory treatment. Hormone replacement treatment.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Pill of 500 mg containing filler agent, two pills daily for eight weeks. | Dietary Supplement: Placebo<br>* Filler agent<br>|
| Experimental: Treatment Group with botanical extracts<br>Pill of 500 mg containing botanicals and filler agent, two pills daily for eight weeks. | Dietary Supplement: Botanical dry extracts combination<br>* Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)] | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)] | 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)] | 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)] | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, Hot flushes, Isoflavones, Aframomum melegueta extract, Punica granatum extract, Cervantes Scale