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临床试验/NCT01315041
NCT01315041已完成1 期

Effects of Homeopathic Medicine "Pi" on Hot Flushes of Women With Menopausal Symptoms

Casa Espirita Terra de Ismael1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
ORIDL (Outcome Related to Impact on Daily Living)

研究概览

简要总结

Hot flushes are common symptoms in women after menopause, and are important causes of discomfort and lead to high number of medical consultations. Hormone replacement therapy is an effective treatment, however it can bring undesirable consequences and may be contraindicated for some women. Options are inhibitors of serotonin or serotonin-norepinephrine reuptake, gabapentin, herbal medicines and homeopathy. None of these therapies is widely accepted of effective. Therefore, the search for new therapeutic options is highly desirable. Ingestion of malagueta pepper fruits (Capsicum frutescens L. var. malagueta) causes sensations similar to those experienced by menopausal women during hot flushes. By the principle of homeopathy, "the like cures the like", the objectives of this study are: (a) to determinate whether pathogenesis of a homeopathic medicine made from C. frutescens fruits include symptoms like hot flushes, and (b) whether this medicine is effective on hot flushes relief in women after menopause. There will be 2 distinct phases. Phase 1 is the determination of the medicine's pathogenesis in healthy volunteers, in a randomized placebo-controlled, double-blind design. Phase 2 is the investigation of the medicine's effects on hot flushes of women after menopause, in a randomized placebo-controlled, double-blind design. The investigators expect a significant reduction on symptoms perception, assessed by internationally validated tools. The study is expected to last for 18 months, with 36 patients included in each phase.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Phase 1: healthy volunteers
  • Phase 2: menopaused women with hot flushes

排除标准

  • Illiteracy;
  • Have been enrolled in another clinical trial within the last 6 months;
  • Use of pharmacological therapies for hot flushes;
  • Have any degree of vulnerability;
  • Allergy or hypersensitivity to Capsicum species;

研究组 & 干预措施

"Pi" medicine

Active Comparator

干预措施: Capsicum frutescens fruits, homeopathic medicine (Drug)

Placebo

Placebo Comparator

干预措施: Inert alcoholic solution (Drug)

结局指标

主要结局

ORIDL (Outcome Related to Impact on Daily Living)

时间窗: 4 and 16 weeks

MYMOP (Measure Yourself Medical Outcome Profile)

时间窗: 4 and 16 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabio Carmona

Assistant Professor

University of Sao Paulo

研究点 (1)

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