"Pi" and Hot Flushes

Phase 1

Completed

• Conditions: Menopausal Symptom Relief
• Interventions: Drug: Capsicum frutescens fruits, homeopathic medicine; Drug: Inert alcoholic solution

• Registration Number: NCT01315041
• Lead Sponsor: Casa Espirita Terra de Ismael

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Study Start: 2014-12
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Pi" medicine	Capsicum frutescens fruits, homeopathic medicine	-
Placebo	Inert alcoholic solution	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Casa Espirita Terra de Ismael; 🇧🇷 Jardinopolis, SP, Brazil