Healthy Subjects
Conditions
Brief summary
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.
Interventions
DRUGHomeopathic 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
OTHERPlacebo
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.
Sponsors
Karl and Veronica Carstens Foundation
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Germany
Outcome results
None listed