Homeopathic Drug Proving Trial

Study Overview
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Brief Summary
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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.

Official Title
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Homeopathic Drug Proving Trial

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Homeopathic drug C12
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical doctors or medical students Not being treated for any acute or chronic diseases on the day of inclusion Written informed consent. Exclusion Criteria: Pregnant women or nursing mothers 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homeopathic drug, potency C12<br> | Drug: Homeopathic drug C12<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 3 weeks |