Casa Espirita Terra de Ismael
Jardinópolis, São Paulo, 14680-000, Brazil
NCT Number: NCT01315041
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.
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Notify Me18 year and older
Female
Interventional
Phase 1 / Phase 2
Jardinópolis, São Paulo, 14680-000, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 drops, PO, 3 times a day, during 16 weeks
5 drops, PO, 3 times a day, during 16 weeks
Time frame: 4 and 16 weeks
Time frame: 4 and 16 weeks
Casa Espirita Terra de Ismael
Other
Effects of Homeopathic Medicine "Pi" on Hot Flushes of Women With Menopausal Symptoms
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