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| Name | Class |
|---|---|
| Karl and Veronica Carstens Foundation | OTHER |
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The main aim of the study is to determine whether a homeopathic drug in the potency C12 provokes more characteristic homeopathic proving symptoms after three weeks compared to a placebo in healthy volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Homeopathic drug, potency C12 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Homeopathic drug C12 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome parameter is the number of characteristic proving symptoms per subject, derived from the qualitative data analysis of the homeopathic proving drug compared to placebo. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of proving symptoms | 3 weeks | |
| Number of serious adverse events | 3 weeks | |
| Qualitative differences in the profiles of characteristic proving symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia M Witt, Prof, MD, MBA | Charité University Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité University | Berlin | State of Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20649979 | Background | 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. | |
| 23561008 | Derived | 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. |
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| Placebo | Other | 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. |
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| 3 weeks |