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临床试验/NCT00617500
NCT00617500Unknown4 期

Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement

Sociedade Hospital Samaritano2 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
278
试验地点
2
主要终点
annoying signs and climacteric symptoms

研究概览

简要总结

The alternative and complementary therapies are being gradually included in the Brazilian Health Unique System (SUS), as it is foreseen in the National Politics of Integrative and Complementary Practices in Brazil . However, though this thematic is also included in the National Agenda of Research Priorities concerning Health, published studies concerning this matter are quite scarce. The World Health Organization (WHO) indicated that it is a big challenge to effect the following studies: cost-effectiveness, as well as safety, efficiency and the quality of such practices. WHO also pointed out the clinical situations where they could be applied and that is why this investigation we are undertaken is fully justified.

Annoying signs and symptoms which come along with the climacteric period, especially anxiety, insomnia and hot flushes, change women´s life quality and their affective, social and business relationships as well. Consequently, this can generate sadness, depression and isolation.

Many women cannot undergo hormonal replacement, for several reasons: or they have some illnesses which reject hormones, or due to hypersensitiveness reactions or even economical difficulties. Also, the cost-effectiveness ratio between conventional therapy of hormonal replacement and complementary therapies which compose this study are not known yet .

The complementary therapies proposed in this study concern non-invasive methods, of low cost, which justify being researched in order to verify the potential of those annoying signs alleviation.

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 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Recruited and registered in local of the study
  • They should present the signs and symptoms checked - insomnia, anxiety and hot flushes, they felt at the beginning of the climacteric
  • They should not be under hormonal replacement or even should have stopped their use more than 90 days
  • Exclusion criteria:
  • women who undergo a hysterectomy surgery
  • women using hormonal therapy

排除标准

  • 未提供

研究组 & 干预措施

Hormone

Active Comparator

干预措施: Hormones (Drug)

flower therapy

Experimental

干预措施: flower therapy (Other)

therapeutic touch

Experimental

干预措施: therapeutic touch (Other)

auriculotherapy

Experimental

干预措施: auricular therapy (Other)

结局指标

主要结局

annoying signs and climacteric symptoms

时间窗: pre and post intervention

次要结局

未报告次要终点

研究者

发起方
Sociedade Hospital Samaritano
申办方类型
Other

研究点 (2)

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