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OpenTrials
Completed

NCT Number: NCT01315041

"Pi" and Hot Flushes

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Casa Espirita Terra de Ismael

Jardinópolis, São Paulo, 14680-000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Capsicum frutescens fruits, homeopathic medicine

Drug

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

Inert alcoholic solution

Drug

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

Primary outcomes

  1. MYMOP (Measure Yourself Medical Outcome Profile)

    Time frame: 4 and 16 weeks

  2. ORIDL (Outcome Related to Impact on Daily Living)

    Time frame: 4 and 16 weeks

Sponsors and collaborators

Lead sponsor

Casa Espirita Terra de Ismael

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 15, 2011
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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