Estromineral Serena Plus and Symptomatic Menopause

Study Overview
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Brief Summary
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Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality of life. The gradual decline of oestrogen from peri-menopause results in altered function of many neurotransmitters, such as dopamine, melatonin and neuropeptides including beta-endorphins, which modulate the function of the hypothalamus and are involved in body thermoregulation. In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2 receptors is effective in relieving hot flushes and in reducing the accompanying psychological symptoms. The use of hormone replacement therapy, which is generally prescribed in the case of moderate or severe symptoms, is limited due to real contraindications or simply the woman's refusal to take the therapy, despite the presence of symptoms requiring its use. A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones, the absorption of which is increased by the presence of Lactobacillus sporogenes, and Vitamin D3 and calcium, strengthening bone mineralization, has been found to be effective at reducing vasomotor symptoms. To potentiate the effect of E on the most frequent symptoms in menopause, it was considered rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste tree, acting on both hot flushes and psychological symptoms and a new food supplement was developed: Estromineral Serena Plus (ESP). Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.

Official Title
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Controlled Clinical Study on the Activity of the Combination of Isoflavones, Agnocastus and Magnolia Extract in Menopause

Conditions
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Menopause

Intervention / Treatment
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* Dietary Supplement: Estromineral Serena Plus
* Dietary Supplement: Estromineral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female menopausal age more than 5 hot flushes/day mood or sleep changes Exclusion Criteria: hormone replacement therapy

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estromineral Serena Plus<br>Estromineral Serena Plus is an association of soy isoflavones, Lactobacillus sporogenes, magnolia, chaste tree, Vitamin D3, calcium and magnesium. 1 tablet oad for 12 weeks | Dietary Supplement: Estromineral Serena Plus<br> <br> |
| Active Comparator: Estromineral<br>Estromineral is an association of soy isoflavones, Lactobacillus sporogenes, Vitamin D3, and calcium. 1 tablet oad for 12 weeks | Dietary Supplement: Estromineral<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kupperman index | To calculate the Kupperman index, the symptoms were weighted as follows: hot flashes (4), insomnia (2), nervousness (2), and all other symptoms (night sweats, depressed mood (melancholy), dizziness, tiredness, joint and muscular pain, headache, and palpitations (1). The highest potential score is thus 51. The score of hot flashes was based on number of complaints per day: slight (more than 5), moderate (5-10), and severe (more than 10) | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Onset duration and severity of adverse events | 4, 8 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, Kupperman, hot flushes, isoflavones, magnolia, chaste tree