"Pi" and Hot Flushes

Effects of Homeopathic Medicine "Pi" on Hot Flushes of Women With Menopausal Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Menopausal Symptom Relief
• Intervention / Treatment: Drug: Capsicum frutescens fruits, homeopathic medicine; Drug: Inert alcoholic solution

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Jardinopolis, SP, Brazil, 14680-000
      • Casa Espirita Terra de Ismael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Inert alcoholic solution; 5 drops, PO, 3 times a day, during 16 weeks
ACTIVE_COMPARATOR: "Pi" medicine	Drug: Capsicum frutescens fruits, homeopathic medicine; 5 drops, PO, 3 times a day, during 16 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Casa Espirita Terra de Ismael
• Collaborators: University of Sao Paulo
• Investigators: Study Director: Fabio Carmona, MD, PhD, University of Sao Paulo; Principal Investigator: Mateus A Angelucci, MD, MSc, University of Sao Paulo; Study Chair: Ana MS Pereira, PhD, University of Ribeirao Preto; Study Director: Edson Z Martinez, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (ESTIMATE): March 15, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Pi2011