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"Pi" and Hot Flushes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01315041
First Posted: March 15, 2011
Last Update Posted: January 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Fabio Carmona, University of Sao Paulo
  Purpose
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 Intervention Phase
Menopausal Symptom Relief Drug: Capsicum frutescens fruits, homeopathic medicine Drug: Inert alcoholic solution Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fabio Carmona, University of Sao Paulo:

Primary Outcome Measures:
  • MYMOP (Measure Yourself Medical Outcome Profile) [ Time Frame: 4 and 16 weeks ]
  • ORIDL (Outcome Related to Impact on Daily Living) [ Time Frame: 4 and 16 weeks ]

Enrollment: 40
Study Start Date: December 2014
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315041


Locations
Brazil
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
  More Information

Responsible Party: Fabio Carmona, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01315041     History of Changes
Other Study ID Numbers: Pi2011
First Submitted: March 14, 2011
First Posted: March 15, 2011
Last Update Posted: January 27, 2016
Last Verified: January 2016