"Pi" and Hot Flushes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Casa Espirita Terra de Ismael.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Casa Espirita Terra de Ismael
ClinicalTrials.gov Identifier:
NCT01315041
First received: March 14, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Casa Espirita Terra de Ismael:

Primary Outcome Measures:
  • MYMOP (Measure Yourself Medical Outcome Profile) [ Time Frame: 4 and 16 weeks ] [ Designated as safety issue: No ]
  • ORIDL (Outcome Related to Impact on Daily Living) [ Time Frame: 4 and 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: April 2011
Estimated Primary Completion Date: March 2012 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315041

Contacts
Contact: Mateus Angelucci, MD, MSc +5516-9722-6326 maangelucci@gmail.com
Contact: Ana MS Pereira, PhD +5516-8156-5654 apereira@unaerp.br

Locations
Brazil
Casa Espirita Terra de Ismael
Jardinopolis, SP, Brazil, 14680-000
Sponsors and Collaborators
Casa Espirita Terra de Ismael
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

No publications provided

Responsible Party: Fabio Carmona, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01315041     History of Changes
Other Study ID Numbers: Pi2011
Study First Received: March 14, 2011
Last Updated: March 14, 2011
Health Authority: Brazil: Ethics Committee

ClinicalTrials.gov processed this record on September 18, 2014