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Pi and Hot Flushes

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01315041
Enrollment
40
Registered
2011-03-15
Start date
2014-12-31
Completion date
2016-01-31
Last updated
2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal Symptom Relief

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.

Interventions

DRUGCapsicum frutescens fruits, homeopathic medicine

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

DRUGInert alcoholic solution

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

Sponsors

University of Sao Paulo
CollaboratorOTHER
Casa Espirita Terra de Ismael
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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;

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026