"Pi" and Hot Flushes
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TilaValmistunut
Sponsorit
Casa Espirita Terra de Ismael
Yhteistyökumppanit
University of Sao Paulo
KLIININEN TUTKIMUS: NCT01315041
BioSeek: NCT01315041
Avainsanat
Abstrakti
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.
Päivämäärät
Viimeksi vahvistettu: | 12/31/2015 |
Ensimmäinen lähetys: | 03/13/2011 |
Arvioitu ilmoittautuminen lähetetty: | 03/13/2011 |
Ensimmäinen lähetetty: | 03/14/2011 |
Viimeisin päivitys lähetetty: | 01/25/2016 |
Viimeisin päivitys lähetetty: | 01/26/2016 |
Todellinen opintojen alkamispäivä: | 11/30/2014 |
Arvioitu ensisijainen valmistumispäivä: | 11/30/2015 |
Arvioitu tutkimuksen valmistumispäivä: | 12/31/2015 |
Ehto tai tauti
Menopausal Symptom Relief
Interventio / hoito
Drug: "Pi" medicine
Drug: Placebo
Vaihe
Vaihe 1/Vaihe 2
Varren ryhmät
Varsi | Interventio / hoito |
---|---|
Active Comparator: "Pi" medicine | Drug: "Pi" medicine 5 drops, PO, 3 times a day, during 16 weeks |
Placebo Comparator: Placebo | Drug: Placebo 5 drops, PO, 3 times a day, during 16 weeks |
Kelpoisuusehdot
Tutkimukseen soveltuvat iät | 18 Years Vastaanottaja 18 Years |
Sukupuolet, jotka ovat kelpoisia tutkimukseen | Female |
Hyväksyy terveelliset vapaaehtoiset | Joo |
Kriteeri | Inclusion Criteria: - Phase 1: healthy volunteers - Phase 2: menopaused women with hot flushes Exclusion Criteria: - 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; |
Tulokset
Ensisijaiset tulosmittaukset
1. MYMOP (Measure Yourself Medical Outcome Profile) [4 and 16 weeks]
2. ORIDL (Outcome Related to Impact on Daily Living) [4 and 16 weeks]