Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2010-03-31
2010-08-31
Brief Summary
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Secondary aims are to develop and to test a qualitative analysis methodology on which to base a definition for drug-specific (characteristic) symptoms and to compile a profile of characteristic homeopathic proving symptoms of the drug being trialled for therapeutic purposes.
This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Homeopathic drug, potency C12
Homeopathic drug C12
Subjects in the intervention group are instructed to take five globules of the trial drug (potency C12), five times per day for a maximum of five days (5×5×5). The study medication is obtained from DHU (Germany), produced according to the Hahnemannian method. Subjects are asked to stop taking the medication, in agreement with their investigator, if they experience any of a predefined set of proving symptoms
Placebo
Placebo
Placebo consists of pure sucrose globules (DHU, Germany) that are not potentiated nor impregnated with alcohol. The administration scheme is identical in the placebo control group to that of the intervention group.
Interventions
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Homeopathic drug C12
Subjects in the intervention group are instructed to take five globules of the trial drug (potency C12), five times per day for a maximum of five days (5×5×5). The study medication is obtained from DHU (Germany), produced according to the Hahnemannian method. Subjects are asked to stop taking the medication, in agreement with their investigator, if they experience any of a predefined set of proving symptoms
Placebo
Placebo consists of pure sucrose globules (DHU, Germany) that are not potentiated nor impregnated with alcohol. The administration scheme is identical in the placebo control group to that of the intervention group.
Eligibility Criteria
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Inclusion Criteria
* Not being treated for any acute or chronic diseases on the day of inclusion
* Written informed consent.
Exclusion Criteria
* Homeopathic treatment over the previous six weeks
* Participation in another clinical trial during the last six months
* Anyone with a personal or professional dependence on the study physician or sponsor
* Anyone who has been placed in hospital or other institution by authorities or decree
18 Years
ALL
Yes
Sponsors
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Karl and Veronica Carstens Foundation
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Claudia M. Witt
Prof. Dr. med.
Principal Investigators
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Claudia M Witt, Prof, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Charité University Berlin
Locations
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Charité University
Berlin, State of Berlin, Germany
Countries
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References
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Teut M, Hirschberg U, Luedtke R, Schnegg C, Dahler J, Albrecht H, Witt CM. Protocol for a phase 1 homeopathic drug proving trial. Trials. 2010 Jul 22;11:80. doi: 10.1186/1745-6215-11-80.
Teut M, Dahler J, Hirschberg U, Luedtke R, Albrecht H, Witt CM. Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial. Trials. 2013 Apr 5;14:96. doi: 10.1186/1745-6215-14-96.
Other Identifiers
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ZS EK 15 - 287/09
Identifier Type: -
Identifier Source: org_study_id