"Pi" and Hot Flushes

NCT01315041 | Completed Phase 1

• 1 other identifier: Pi2011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopausal Symptom Relief

Outcome Measures

Primary Outcomes (2)

• MYMOP (Measure Yourself Medical Outcome Profile)

  4 and 16 weeks

• ORIDL (Outcome Related to Impact on Daily Living)

  4 and 16 weeks

Study Arms (2)

"Pi" medicine

ACTIVE COMPARATOR

Drug: Capsicum frutescens fruits, homeopathic medicine

Placebo

PLACEBO COMPARATOR

Drug: Inert alcoholic solution

Interventions

Capsicum frutescens fruits, homeopathic medicine DRUG

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

"Pi" medicine

Inert alcoholic solution DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 1: healthy volunteers
• Phase 2: menopaused women with hot flushes

You may not qualify if:

• 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;

Sponsors & Collaborators

• Casa Espirita Terra de Ismael: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Casa Espirita Terra de Ismael

Jardinópolis, São Paulo, 14680-000, Brazil

Location

MeSH Terms

Interventions

Homeopathy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Fabio Carmona, MD, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Mateus A Angelucci, MD, MSc

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Ana MS Pereira, PhD

  University of Ribeirao Preto

  STUDY CHAIR

• Edson Z Martinez, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

BR (1)