NCT04381026

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Nektium Pharma SL · Industry
• Sex: Female
• Age: 45 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause
• Dietary Supplements
• Quality of Life

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Botanical dry extracts combination	Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)
DIETARY_SUPPLEMENT	Placebo	Filler agent

Timeline

• Start date: 2017-04-19
• Primary completion: 2018-06-06
• Completion: 2018-07-10
• First posted: 2020-05-08
• Last updated: 2020-05-08

Locations

1 site across 1 country: Spain