Homeopathic Drug Proving Trial (HAMSV)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||Homeopathic Drug Proving Trial|
- 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. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Total number of proving symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Number of serious adverse events [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Qualitative differences in the profiles of characteristic proving symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Experimental: Homeopathic drug, potency C12||
Drug: 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 Comparator: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061229
|Berlin, Germany, 10117|
|Principal Investigator:||Claudia M Witt, Prof, MD, MBA||Charité University Berlin|