"Pi" and Hot Flushes
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Menopausal Symptom Relief |
Drug: Capsicum frutescens fruits, homeopathic medicine Drug: Inert alcoholic solution |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Homeopathic Medicine "Pi" on Hot Flushes of Women With Menopausal Symptoms |
- MYMOP (Measure Yourself Medical Outcome Profile) [ Time Frame: 4 and 16 weeks ] [ Designated as safety issue: No ]
- ORIDL (Outcome Related to Impact on Daily Living) [ Time Frame: 4 and 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: "Pi" medicine |
Drug: Capsicum frutescens fruits, homeopathic medicine
5 drops, PO, 3 times a day, during 16 weeks
|
| Placebo Comparator: Placebo |
Drug: Inert alcoholic solution
5 drops, PO, 3 times a day, during 16 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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;
Contacts and Locations| Contact: Mateus Angelucci, MD, MSc | +5516-9722-6326 | maangelucci@gmail.com |
| Contact: Ana MS Pereira, PhD | +5516-8156-5654 | apereira@unaerp.br |
| Brazil | |
| Casa Espirita Terra de Ismael | |
| Jardinopolis, SP, Brazil, 14680-000 | |
| Study Director: | Fabio Carmona, MD, PhD | University of Sao Paulo |
| Principal Investigator: | Mateus A Angelucci, MD, MSc | University of Sao Paulo |
| Study Chair: | Ana MS Pereira, PhD | University of Ribeirao Preto |
| Study Director: | Edson Z Martinez, PhD | University of Sao Paulo |
More Information
No publications provided
| Responsible Party: | Fabio Carmona, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01315041 History of Changes |
| Other Study ID Numbers: | Pi2011 |
| Study First Received: | March 14, 2011 |
| Last Updated: | March 14, 2011 |
| Health Authority: | Brazil: Ethics Committee |
ClinicalTrials.gov processed this record on May 19, 2013