"Pi" and Hot Flushes

Sponsor

Casa Espirita Terra de Ismael (Other)

Overall Status

Completed

CT.gov ID

NCT01315041

Collaborator

University of Sao Paulo (Other)

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopausal Symptom Relief	Drug: Capsicum frutescens fruits, homeopathic medicine Drug: Inert alcoholic solution	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: "Pi" medicine

Drug: Capsicum frutescens fruits, homeopathic medicine

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

Placebo Comparator: Placebo

Drug: Inert alcoholic solution

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Casa Espirita Terra de Ismael	Jardinopolis	SP	Brazil	14680-000

Sponsors and Collaborators

Casa Espirita Terra de Ismael
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fabio Carmona, Assistant Professor, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01315041

Other Study ID Numbers:

Pi2011

First Posted:

Mar 15, 2011

Last Update Posted:

Jan 27, 2016

Last Verified:

Jan 1, 2016

Study Results

No Results Posted as of Jan 27, 2016