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临床试验/NCT01730989
NCT01730989Unknown不适用

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

Rottapharm2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
Rottapharm
入组人数
300
试验地点
2
主要终点
Kupperman index

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female menopausal age
  • more than 5 hot flushes/day
  • mood or sleep changes

排除标准

  • hormone replacement therapy

结局指标

主要结局

Kupperman index

时间窗: up to 12 weeks

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)

次要结局

  • Adverse events(4, 8 and 12 weeks)

研究者

发起方
Rottapharm
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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