"Pi" and Hot Flushes

Casa Espirita Terra de Ismael

Status and phase: Completed; Phase 2; Phase 1

Conditions: Menopausal Symptom Relief

Treatments: Drug: Inert alcoholic solution; Drug: Capsicum frutescens fruits, homeopathic medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT01315041

Pi2011

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

"Pi" medicine

Active Comparator group

Treatment:

Drug: Capsicum frutescens fruits, homeopathic medicine

Placebo

Placebo Comparator group

Treatment:

Drug: Inert alcoholic solution