MenopauseNCT04381026

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

A study testing Botanical dry extracts combination in people with Menopause and Dietary Supplements, run by Nektium Pharma SL at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 45 to 55 years, women only
Conditions the study is for: Menopause, Dietary Supplements, Quality of Life
What is being tested?: Botanical dry extracts combination
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteSpain
Study dates: 19 Apr 2017to 10 Jul 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 55 years
Women only
No healthy volunteers
Adult

Who may be able to join

Women in the Climacteric Phase under medical criteria based on Health questionnaire, Blood and urine test.
Informed consent to participate in the study.

Who cannot join

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 locations and contacts

1 site in 1 country.

Spain1 site

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

Other trials in Spain

About this study

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

Read the 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
Being tested: Botanical dry extracts combination, Placebo
Keywords: Menopause, Hot flushes, Isoflavones, Aframomum melegueta extract, Punica granatum extract, Cervantes Scale
Medical subject headings: Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botanical dry extracts combinationDietary supplement
Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)
PlaceboDietary supplement
Filler agent

Study groups in NCT04381026
Study group	Role	What they receive
Placebo Group	Placebo comparator	Pill of 500 mg containing filler agent, two pills daily for eight weeks. Receives: Dietary Supplement: Placebo
Treatment Group with botanical extracts	Experimental	Pill of 500 mg containing botanicals and filler agent, two pills daily for eight weeks. Receives: Dietary Supplement: Botanical dry extracts combination

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline to Week 8 in the global score of quality of life using the validated Cervantes Scale
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)]
Measured: 8 weeks

Secondary outcomes (3)

Change from Baseline to Week 8 in the Menopause-health score of quality of life using the validated Cervantes Scale
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)]
Measured: 8 weeks
Change from Baseline to Week 8 in the psychic score of quality of life using the validated Cervantes Scale
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)]
Measured: 8 weeks
Change from Baseline to Week 8 in the sexuality-couple score of quality of life using the validated Cervantes Scale.
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)]
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 201710 Jul 2018

First posted8 May 2020
Study start19 Apr 2017
Primary completion6 Jun 2018
Study completion10 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for MenopauseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04381026
Sponsor's protocol ID: PRO_WH_HCT_2016.01
Status last verified: May 2020
First submitted: 5 May 2020
Last updated: 8 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.
PubMed 9643514
Buendia Bermejo J, Rodriguez Segarra R, Yubero Bascunana N, Martinez Vizcaino V. [Design and validation of a questionnaire in Spanish for measuring the quality of life in postmenopausal women: the MENCAV questionnaire]. Aten Primaria. 2001 Feb 15;27(2):94-100. doi: 10.1016/s0212-6567(01)78780-x. Spanish.
PubMed 11256098
Palacios S, Ferrer-Barriendos J, Parrilla JJ, Castelo-Branco C, Manubens M, Alberich X, Marti A; Grupo Cervantes. [Health-related quality of life in the Spanish women through and beyond menopause. Development and validation of the Cervantes Scale]. Med Clin (Barc). 2004 Feb 21;122(6):205-11. doi: 10.1016/s0025-7753(04)74198-6. Spanish.
PubMed 15012887
Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
PubMed 15345062
Low Dog T. Menopause: a review of botanical dietary supplements. Am J Med. 2005 Dec 19;118 Suppl 12B:98-108. doi: 10.1016/j.amjmed.2005.09.044.
PubMed 16414334
Tranche S, Brotons C, Pascual de la Pisa B, Macias R, Hevia E, Marzo-Castillejo M. Impact of a soy drink on climacteric symptoms: an open-label, crossover, randomized clinical trial. Gynecol Endocrinol. 2016 Jun;32(6):477-82. doi: 10.3109/09513590.2015.1132305. Epub 2016 Jan 25.
PubMed 26806546
Kang SJ, Choi BR, Kim SH, Yi HY, Park HR, Kim DC, Choi SH, Han CH, Park SJ, Song CH, Ku SK, Lee YJ. Dried pomegranate potentiates anti-osteoporotic and anti-obesity activities of red clover dry extracts in ovariectomized rats. Nutrients. 2015 Apr 9;7(4):2622-47. doi: 10.3390/nu7042622.
PubMed 25912038
Balk E, Chung M, Chew P, Ip S, Raman G, Kupelnick B, Tatsioni A, Sun Y, Wolk B, DeVine D, Lau J. Effects of soy on health outcomes. Evid Rep Technol Assess (Summ). 2005 Aug;(126):1-8. doi: 10.1037/e439502005-001. No abstract available.
PubMed 16194125
Ferrari A. Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms. J Obstet Gynaecol Res. 2009 Dec;35(6):1083-90. doi: 10.1111/j.1447-0756.2009.01058.x.
PubMed 20025635
Klein MA, Nahin RL, Messina MJ, Rader JI, Thompson LU, Badger TM, Dwyer JT, Kim YS, Pontzer CH, Starke-Reed PE, Weaver CM. Guidance from an NIH workshop on designing, implementing, and reporting clinical studies of soy interventions. J Nutr. 2010 Jun;140(6):1192S-1204S. doi: 10.3945/jn.110.121830. Epub 2010 Apr 14.
PubMed 20392880
Munro IC, Harwood M, Hlywka JJ, Stephen AM, Doull J, Flamm WG, Adlercreutz H. Soy isoflavones: a safety review. Nutr Rev. 2003 Jan;61(1):1-33. doi: 10.1301/nr.2003.janr.1-33.
PubMed 12638461
Satpathy S, Patra A, Purohit AP. Estrogenic activity of Punica granatum L. peel extract. Asian Pacific J. Reprod. 2013; 2(1): 19-24
Bialonska D, Ramnani P, Kasimsetty SG, Muntha KR, Gibson GR, Ferreira D. The influence of pomegranate by-product and punicalagins on selected groups of human intestinal microbiota. Int J Food Microbiol. 2010 Jun 15;140(2-3):175-82. doi: 10.1016/j.ijfoodmicro.2010.03.038. Epub 2010 Apr 2.
PubMed 20452076
Mori-Okamoto J, Otawara-Hamamoto Y, Yamato H, Yoshimura H. Pomegranate extract improves a depressive state and bone properties in menopausal syndrome model ovariectomized mice. J Ethnopharmacol. 2004 May;92(1):93-101. doi: 10.1016/j.jep.2004.02.006.
PubMed 15099854
Ilic NM, Dey M, Poulev AA, Logendra S, Kuhn PE, Raskin I. Anti-inflammatory activity of grains of paradise (Aframomum melegueta Schum) extract. J Agric Food Chem. 2014 Oct 29;62(43):10452-7. doi: 10.1021/jf5026086. Epub 2014 Oct 20.
PubMed 25293633

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Menopause trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on the Effect of a Nutritional Supplement With Isoflavones on the Symptoms of Climacteric in Healthy Women
ClinicalTrials.gov ID: NCT04381026
Acronym / sponsor ID: PRO_WH_HCT_2016.01
Conditions: Menopause, Dietary Supplements, Quality of Life
Keywords: Menopause, Hot flushes, Isoflavones, Aframomum melegueta extract, Punica granatum extract, Cervantes Scale
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Nektium Pharma SLIndustry (pharma, biotech, devices)
Collaborators: Clínica Barem
Study start: 19 Apr 2017 (actual)
Primary completion: 6 Jun 2018 (actual)
Study completion: 10 Jul 2018 (actual)
First posted: 8 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo Group	Placebo comparator	Dietary Supplement: PlaceboPill of 500 mg containing filler agent, two pills daily for eight weeks.
Treatment Group with botanical extracts	Experimental	Dietary Supplement: Botanical dry extracts combinationPill of 500 mg containing botanicals and filler agent, two pills daily for eight weeks.

Who may qualify

Ages: 45 to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Women in the Climacteric Phase under medical criteria based on Health questionnaire, Blood and urine test.
Informed consent to participate in the study.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Botanical dry extracts combinationAframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)	Dietary supplement	Treatment Group with botanical extracts
PlaceboFiller agent	Dietary supplement	Placebo Group

Primary outcome

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)]

3 secondary outcomes

Change from Baseline to Week 8 in the Menopause-health score of quality of life using the validated Cervantes Scale
Time frame: 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
Change from Baseline to Week 8 in the sexuality-couple score of quality of life using the validated Cervantes Scale.
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
Results publication: PubMed 9643514Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.
Results publication: PubMed 11256098Buendia Bermejo J, Rodriguez Segarra R, Yubero Bascunana N, Martinez Vizcaino V. [Design and validation of a questionnaire in Spanish for measuring the quality of life in postmenopausal women: the MENCAV questionnaire]. Aten Primaria. 2001 Feb 15;27(2):94-100. doi: 10.1016/s0212-6567(01)78780-x. Spanish.
Results publication: PubMed 15012887Palacios S, Ferrer-Barriendos J, Parrilla JJ, Castelo-Branco C, Manubens M, Alberich X, Marti A; Grupo Cervantes. [Health-related quality of life in the Spanish women through and beyond menopause. Development and validation of the Cervantes Scale]. Med Clin (Barc). 2004 Feb 21;122(6):205-11. doi: 10.1016/s0025-7753(04)74198-6. Spanish.
Results publication: PubMed 15345062Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
Results publication: PubMed 16414334Low Dog T. Menopause: a review of botanical dietary supplements. Am J Med. 2005 Dec 19;118 Suppl 12B:98-108. doi: 10.1016/j.amjmed.2005.09.044.
Results publication: PubMed 26806546Tranche S, Brotons C, Pascual de la Pisa B, Macias R, Hevia E, Marzo-Castillejo M. Impact of a soy drink on climacteric symptoms: an open-label, crossover, randomized clinical trial. Gynecol Endocrinol. 2016 Jun;32(6):477-82. doi: 10.3109/09513590.2015.1132305. Epub 2016 Jan 25.
Results publication: PubMed 25912038Kang SJ, Choi BR, Kim SH, Yi HY, Park HR, Kim DC, Choi SH, Han CH, Park SJ, Song CH, Ku SK, Lee YJ. Dried pomegranate potentiates anti-osteoporotic and anti-obesity activities of red clover dry extracts in ovariectomized rats. Nutrients. 2015 Apr 9;7(4):2622-47. doi: 10.3390/nu7042622.
Results publication: PubMed 16194125Balk E, Chung M, Chew P, Ip S, Raman G, Kupelnick B, Tatsioni A, Sun Y, Wolk B, DeVine D, Lau J. Effects of soy on health outcomes. Evid Rep Technol Assess (Summ). 2005 Aug;(126):1-8. doi: 10.1037/e439502005-001. No abstract available.
Results publication: PubMed 20025635Ferrari A. Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms. J Obstet Gynaecol Res. 2009 Dec;35(6):1083-90. doi: 10.1111/j.1447-0756.2009.01058.x.
Results publication: PubMed 20392880Klein MA, Nahin RL, Messina MJ, Rader JI, Thompson LU, Badger TM, Dwyer JT, Kim YS, Pontzer CH, Starke-Reed PE, Weaver CM. Guidance from an NIH workshop on designing, implementing, and reporting clinical studies of soy interventions. J Nutr. 2010 Jun;140(6):1192S-1204S. doi: 10.3945/jn.110.121830. Epub 2010 Apr 14.
Results publication: PubMed 12638461Munro IC, Harwood M, Hlywka JJ, Stephen AM, Doull J, Flamm WG, Adlercreutz H. Soy isoflavones: a safety review. Nutr Rev. 2003 Jan;61(1):1-33. doi: 10.1301/nr.2003.janr.1-33.
Results publicationSatpathy S, Patra A, Purohit AP. Estrogenic activity of Punica granatum L. peel extract. Asian Pacific J. Reprod. 2013; 2(1): 19-24
Clinical guides for menopause from AEEMLink provided by the sponsor.
paper on Validity and reliability of the Kupperman test \[Spanish\]Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura López-Ríos, PhD principal investigator

Nektium Pharma SL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Botanical dry extracts combination in people with Menopause and Dietary Supplements, run by Nektium Pharma SL at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline to Week 8 in the global score of quality of life using the validated Cervantes Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04381026, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.