Clinical trial NCT01315041: "Pi" and Hot Flushes
Official title: Effects of Homeopathic Medicine "Pi" on Hot Flushes of Women With Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Menopausal Symptom Relief
Lead sponsor: Casa Espirita Terra de Ismael
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2011-03-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: MYMOP (Measure Yourself Medical Outcome Profile)
timeFrame: 4 and 16 weeks
measure: ORIDL (Outcome Related to Impact on Daily Living)
timeFrame: 4 and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jardinopolis
country: Brazil
facility: Casa Espirita Terra de Ismael
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Fabio Carmona, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Mateus A Angelucci, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ribeirao Preto
name: Ana MS Pereira, PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Edson Z Martinez, PhD
role: STUDY_DIRECTOR
References: