Pi and Hot Flushes

Study Overview
=================
Brief 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.

Official Title
-----------------
Effects of Homeopathic Medicine Pi on Hot Flushes of Women With Menopausal Symptoms

Conditions
-----------------
Menopausal Symptom Relief

Intervention / Treatment
-----------------
* Drug: Capsicum frutescens fruits, homeopathic medicine
* Drug: Inert alcoholic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pi medicine<br> | Drug: Capsicum frutescens fruits, homeopathic medicine<br>* 5 drops, PO, 3 times a day, during 16 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Inert alcoholic solution<br>* 5 drops, PO, 3 times a day, during 16 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MYMOP (Measure Yourself Medical Outcome Profile) |  | 4 and 16 weeks | 
| ORIDL (Outcome Related to Impact on Daily Living) |  | 4 and 16 weeks |