Menopausal Symptom ReliefPhase 1/2NCT01315041
"Pi" and Hot Flushes
A Phase 1/2 study testing Capsicum frutescens fruits, homeopathic medicine and Inert alcoholic solution in people with Menopausal Symptom Relief, run by Casa Espirita Terra de Ismael at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Symptom Relief
- What is being tested?
- Capsicum frutescens fruits, homeopathic medicine and Inert alcoholic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2014to Jan 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase 1: healthy volunteers
- Phase 2: menopaused women with hot flushes
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Homeopathic Medicine "Pi" on Hot Flushes of Women With Menopausal Symptoms
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
- Being tested
- Capsicum frutescens fruits, homeopathic medicine, Inert alcoholic solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsicum frutescens fruits, homeopathic medicineDrug
5 drops, PO, 3 times a day, during 16 weeks
Inert alcoholic solutionDrug
5 drops, PO, 3 times a day, during 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| "Pi" medicine | Active comparator | Not described Receives: Drug: Capsicum frutescens fruits, homeopathic medicine |
| Placebo | Placebo comparator | Not described Receives: Drug: Inert alcoholic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
MYMOP (Measure Yourself Medical Outcome Profile)
Measured: 4 and 16 weeks
ORIDL (Outcome Related to Impact on Daily Living)
Measured: 4 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal Symptom ReliefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa Espirita Terra de Ismael
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Fabio Carmona, University of Sao Paulo
- Investigators
- Fabio Carmona, MD, PhD, Study director, University of Sao PauloMateus A Angelucci, MD, MSc, Principal investigator, University of Sao PauloAna MS Pereira, PhD, Study chair, University of Ribeirao PretoEdson Z Martinez, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315041
- Sponsor's protocol ID
- Pi2011
- Status last verified
- Jan 2016
- First submitted
- 14 Mar 2011
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Homeopathic Medicine "Pi" on Hot Flushes of Women With Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT01315041
- Acronym / sponsor ID
- Pi2011
- Conditions
- Menopausal Symptom Relief
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Casa Espirita Terra de IsmaelUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Pi" medicine | Active comparator | Drug: Capsicum frutescens fruits, homeopathic medicine |
| Placebo | Placebo comparator | Drug: Inert alcoholic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Phase 1: healthy volunteers
- Phase 2: menopaused women with hot flushes
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsicum frutescens fruits, homeopathic medicine5 drops, PO, 3 times a day, during 16 weeks | Drug | "Pi" medicine |
| Inert alcoholic solution5 drops, PO, 3 times a day, during 16 weeks | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Carmona, MD, PhD study director
University of Sao Paulo
Mateus A Angelucci, MD, MSc principal investigator
University of Sao Paulo
Ana MS Pereira, PhD study chair
University of Ribeirao Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Capsicum frutescens fruits, homeopathic medicine and Inert alcoholic solution in people with Menopausal Symptom Relief, run by Casa Espirita Terra de Ismael at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MYMOP (Measure Yourself Medical Outcome Profile) (time frame: 4 and 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.