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

May 5, 2020 updated by: Nektium Pharma SL

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

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
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)]
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
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)]
8 weeks
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)]
8 weeks
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)]
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)]
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nektium Pharma SL

Collaborators

Clínica Barem

Investigators

  • Principal Investigator: Laura López-Ríos, PhD, Nektium Pharma SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2017

Primary Completion (Actual)

June 6, 2018

Study Completion (Actual)

July 10, 2018

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO_WH_HCT_2016.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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