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

Nektium Pharma

Status: Completed

Conditions: Quality of Life; Menopause; Dietary Supplements

Treatments: Dietary Supplement: Botanical dry extracts combination; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04381026

PRO_WH_HCT_2016.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Pill of 500 mg containing filler agent, two pills daily for eight weeks.

Treatment:

Dietary Supplement: Placebo

Treatment Group with botanical extracts

Experimental group

Description:

Pill of 500 mg containing botanicals and filler agent, two pills daily for eight weeks.

Treatment:

Dietary Supplement: Botanical dry extracts combination