Clinical trial NCT04381026: Effects of a New Botanical Extracts Combination on Quality of Life in Menopausal Spanish Women
Official title: Study on the Effect of a Nutritional Supplement With Isoflavones on the Symptoms of Climacteric in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Dietary Supplements
Quality of Life
Keywords: Menopause
Hot flushes
Isoflavones
Aframomum melegueta extract
Punica granatum extract
Cervantes Scale
Lead sponsor: Nektium Pharma SL
Sponsor class: INDUSTRY
Collaborators: name: Clínica Barem
First posted: 2020-05-08
Enrollment: 57
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline to Week 8 in the global score of quality of life using the validated Cervantes Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from Baseline to Week 8 in the Menopause-health score of quality of life using the validated Cervantes Scale
timeFrame: 8 weeks
measure: Change from Baseline to Week 8 in the psychic score of quality of life using the validated Cervantes Scale
timeFrame: 8 weeks
measure: Change from Baseline to Week 8 in the sexuality-couple score of quality of life using the validated Cervantes Scale.
timeFrame: 8 weeks
Other outcomes:
measure: Change from baseline to week 8 in the bogy weight
timeFrame: 8 weeks
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Clinica Barem
state: Las Palmas (Canary Islands)
Study officials:
affiliation: Nektium Pharma SL
name: Laura López-Ríos, PhD
role: PRINCIPAL_INVESTIGATOR
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