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Completed

NCT Number: NCT04381026

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

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.

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Key information

Conditions

Menopause Dietary Supplements Hot Flashes Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Barem

Las Palmas de Gran Canaria, Las Palmas (Canary Islands), 35005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botanical dry extracts combination

Dietary Supplement

Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)

Placebo

Dietary Supplement

Filler agent

Primary outcomes

  1. Change from Baseline to Week 8 in the global score of quality of life using the validated Cervantes Scale

    Time frame: 8 weeks

    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)]

Secondary outcomes

  1. Change from Baseline to Week 8 in the Menopause-health score of quality of life using the validated Cervantes Scale

    Time frame: 8 weeks

    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)]

  2. Change from Baseline to Week 8 in the psychic score of quality of life using the validated Cervantes Scale

    Time frame: 8 weeks

    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)]

  3. Change from Baseline to Week 8 in the sexuality-couple score of quality of life using the validated Cervantes Scale.

    Time frame: 8 weeks

    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)]

Other outcomes

  1. Change from baseline to week 8 in the bogy weight

    Time frame: 8 weeks

    To evaluate the body weight reduccion, a variable to quantify the percentage of reduction between after-treatment and before-treatment in body weight (BW) is generated: [Variation%=100 x ((initial BW value-final BW value)/ initial BW value)]

Sponsors and collaborators

Lead sponsor

Nektium Pharma SL

Industry

Collaborators

  • Clínica Barem

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 8, 2020
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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