"Pi" and Hot Flushes

Summary

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.

Conditions

• Menopausal Symptom Relief

Interventions

DRUG

Capsicum frutescens fruits, homeopathic medicine

5 drops, PO, 3 times a day, during 16 weeks

DRUG

Inert alcoholic solution

5 drops, PO, 3 times a day, during 16 weeks

Sponsors & Collaborators

• University of Sao Paulo

  collaborator OTHER

• Casa Espirita Terra de Ismael

  lead OTHER

Principal Investigators

• Fabio Carmona, MD, PhD · University of Sao Paulo

• Mateus A Angelucci, MD, MSc · University of Sao Paulo

• Ana MS Pereira, PhD · University of Ribeirao Preto

• Edson Z Martinez, PhD · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2015-12-31

Completion

2016-01-31

Countries

• Brazil

Study Locations