"Pi" and Hot Flushes

NCT ID: NCT01315041

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-01-31

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.

Conditions

Menopausal Symptom Relief

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

"Pi" medicine

Group Type: ACTIVE_COMPARATOR

Capsicum frutescens fruits, homeopathic medicine

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Inert alcoholic solution

Intervention Type: DRUG

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

Interventions

Capsicum frutescens fruits, homeopathic medicine

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

Intervention Type: DRUG

Inert alcoholic solution

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

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Casa Espirita Terra de Ismael

OTHER

Sponsor Role: lead

Responsible Party

Fabio Carmona

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edson Z Martinez, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Fabio Carmona, MD, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Mateus A Angelucci, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Ana MS Pereira, PhD

Role: STUDY_CHAIR

University of Ribeirao Preto

Locations

Casa Espirita Terra de Ismael

Jardinópolis, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Pi2011

Identifier Type: -

Identifier Source: org_study_id