To record all reactions of healthy volunteers induced by the use of a homeopathic medicine and placebo.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
nvt betreft homeopathische geneesmiddelproef bij gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proving symptoms experienced by the volunteers and attributable to the
administration of the homeopathic medicine or placebo. For each symptom its
properties are recorded according to a predefined scheme.
Secondary outcome
not applicable
Background summary
Homeopathy is a medical system, founded by Samuel Hahnemann in 1796. The three
main principles of this system are a) testing the effects of medicines on
healthy volunteers (proving), b) the law of similars, and c) the use of
potentised medicines. The *law of similars* states, that a homeopathic
medicine, capable of provoking symptoms in a healthy person (a proving), acts
as curative agent in a diseased person in which similar symptoms are
manifested. Homeopathic Drug Provings (HDP) are thus necessary to provide
information to prescribe the medicine for patients according to the law of
similars, as well as for market authorisation of homeopathic medicinal
products.
Study objective
To record all reactions of healthy volunteers induced by the use of a
homeopathic medicine and placebo.
Study design
Randomised, double-blind, placebo-controlled study
Intervention
Homeopathic Medicine Aspergillus ruber C12 for oral administration versus
placebo
Study burden and risks
The investigational product can cause reactions in participants, however they
will be mild of nature and of a short duration. No serious adverse events have
been reported. The investigational product as studied in the present study is
in a dilution beyond Avogadro*s number. The study-related investment for
participants is estimated to be maximum 47 hours over a period of 4 months. The
most intensive period is in the first two weeks after start of the study.
Travelling burden for the participants will be minimized to two or three times
during the course of the study since contact by phone is planned as much as
possible and supervisors are also willing to travel. Based on the time
investment described above and the extremely low risk for the occurence of
possible serious side effects, the advantages of contributing to the further
development and availability of homeopathic medicinal products do outweight the
study burden and possible risks.
Hasseler Steinweg 9
Hoya 27318
DE
Hasseler Steinweg 9
Hoya 27318
DE
Listed location countries
Age
Inclusion criteria
•Between 18 years and 75 years old.
•Written informed consent
•Able to understand and read the Dutch language
•Accessible by telephone or internet
Exclusion criteria
•Subjects with serious mental-emotional disorders such as
psychosis, major depression, anxiety disorder, bipolar disorder or similar.
•Planned medical/dental treatment during the HDP, including
herbal or dietary supplements, procedures or medications that
might interfere with, or substantially alter responsiveness of the
participants to the homeopathic medicine proved. The use of
contraceptive medication or intra-uterine devices is not an
exclusion criterion.
•Pregnancy or lactation, or anticipating pregnancy during the
course of the HPD.
•A known history of drug, alcohol and/or medication dependence
or addiction
•Participation in another trial at the same time or within the last 3
months prior to the study.
•Current homeopathic treatment, or homeopathic treatment
within 30 days prior to the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001239-35-NL |
| CCMO | NL48326.028.14 |