Healthy Subjects Clinical Trial
— HAMSVOfficial title:
Homeopathic Drug Proving Trial
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | August 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Germany | Charité University | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | Karl and Veronica Carstens Foundation |
Germany,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Total number of proving symptoms | 3 weeks | No | |
Secondary | Number of serious adverse events | 3 weeks | Yes | |
Secondary | Qualitative differences in the profiles of characteristic proving symptoms | 3 weeks | No |
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