Healthy SubjectsPhase 1HAMSVNCT01061229
Homeopathic Drug Proving Trial
A Phase 1 study testing Homeopathic drug C12 in people with Healthy Subjects, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Homeopathic drug C12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical doctors or medical students
- Not being treated for any acute or chronic diseases on the day of inclusion
- Written informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Subjects
- Being tested
- Homeopathic drug C12, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeopathic drug C12Drug
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
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Homeopathic drug, potency C12 | Experimental | Not described Receives: Drug: Homeopathic drug C12 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (3)
Total number of proving symptoms
Measured: 3 weeks
Number of serious adverse events
Measured: 3 weeks
Qualitative differences in the profiles of characteristic proving symptoms
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M Witt, Prof, MD, MBA, Principal investigator, Charité University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061229
- Sponsor's protocol ID
- ZS EK 15 - 287/09
- Acronym
- HAMSV
- Status last verified
- Jul 2012
- First submitted
- 2 Feb 2010
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20649979Teut M, Dahler J, Hirschberg U, Luedtke R, Albrecht H, Witt CM. Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial. Trials. 2013 Apr 5;14:96. doi: 10.1186/1745-6215-14-96.
PubMed 23561008
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeopathic Drug Proving Trial
- ClinicalTrials.gov ID
- NCT01061229
- Acronym / sponsor ID
- HAMSV / ZS EK 15 - 287/09
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homeopathic drug, potency C12 | Experimental | Drug: Homeopathic drug C12 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical doctors or medical students
- Not being treated for any acute or chronic diseases on the day of inclusion
- Written informed consent.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeopathic drug C12Subjects 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 | Drug | Homeopathic drug, potency C12 |
| PlaceboPlacebo 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. | Other | Placebo |
Primary outcome
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
3 secondary outcomes
Total number of proving symptoms
Time frame: 3 weeks
Number of serious adverse events
Time frame: 3 weeks
Qualitative differences in the profiles of characteristic proving symptoms
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Background: PubMed 20649979Teut 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.
- Derived from this study: PubMed 23561008Teut M, Dahler J, Hirschberg U, Luedtke R, Albrecht H, Witt CM. Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial. Trials. 2013 Apr 5;14:96. doi: 10.1186/1745-6215-14-96.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia M Witt, Prof, MD, MBA principal investigator
Charité University Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Homeopathic drug C12 in people with Healthy Subjects, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01061229, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.