HealthyNCT00809263
Homeopathic Drug Provings
A study testing homeopathic remedy in people with Healthy, run by Integrative Medicine Institute at 1 site in United States.
Trial summary
In a homeopathic drug proving a homeopathically prepared substance is administered to healthy volunteers in order to produce the symptoms specific to that substance and thereby reveal its inherent curative powers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- homeopathic remedy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2012
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years and < 75 years
- General state of good health
- Continuation of the usual habits and patterns of daily living
- Written informed consent obtained and willingness to comply with the requirements of the study
Who cannot join
- Any major life changes e.g. moving, getting married or divorced etc.
- Current or expected medical treatment or surgery during this homeopathic drug proving
- Surgery within the past four weeks prior to enrollment into the homeopathic drug proving
- Use of homeopathic medicines > 30 C or contraceptive pills in the month prior to enrollment into the homeopathic drug proving
- Alcohol or drug abuse
- Pregnancy or nursing (or anticipating pregnancy during this homeopathic drug proving)
- Incompetence, or inability of understanding the nature, meaning and consequences of the homeopathic drug proving or inadequate completion of the journal form DAY 1-7.
- Participation in another clinical trial at the same time or within the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest College of Naturopathic Medicine
Tempe, Arizona, 85282
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Homeopathic Drug Proving Using a Crossover Design
In a homeopathic drug proving a homeopathically prepared substance is administered to healthy volunteers in order to produce the symptoms specific to that substance and thereby reveal its inherent curative powers. During a homeopathic drug proving the goal is to provoke temporary symptoms (or "artificial illness") associated with the homeopathic medication. These symptoms are then arranged to form a symptom pattern or 'remedy picture' which is specific to that particular homeopathic substance and provides the basis for a better understanding of the possible effects of that homeopathic remedy in patients.
Read the detailed description
The duration of these homeopathic drug provings are six week per subject (42 days). The central investigational tool of the homeopathic drug proving is the journal kept by each subject from DAY 1-35. The subject describes the symptoms they experience in their own words in the journal daily. During the 7 day run-in phase, the subject notes in their journal their current state of health, the daily rhythm of their life, and any other signs or symptoms that occur on a daily basis. This will also enhance familiarity with self-observation and the recording of signs and symptoms. After completion of this run-in phase an evaluation including journal check will occur on DAY 7. During the following 4 weeks (observation periods DAY 8-14, 22-28; wash-out period DAY 15-21 and 29 - 35) the subject documents all signs or symptoms that occur in his/her journal on a daily basis. During this period, subject interviews will take place on DAY 15, DAY 21. DAY 29 and DAY 36. During the 7 day follow up (post observation period, DAY 36-42) the subject will be contacted to check if any additional symptoms and/or adverse events occurred.
- Conditions
- Healthy
- Being tested
- homeopathic remedy
- Keywords
- homeopathy, homeopathic drug proving, Document symptoms associated with administration of a homeopathic remedy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
homeopathic remedyDrug
Homeopathic remedy 12C potency, 10 drops TID X 7 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms associated with the administration of homeopathic remedy to health subjects.
Measured: 6 weeks per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startOct 2009
- Primary completionJan 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest College of Naturopathic Medicine, Heel GmbH
- Investigators
- Steven Messer, ND, Principal investigator, Southwest College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809263
- Sponsor's protocol ID
- HDPSCNM2008
- Status last verified
- Feb 2014
- First submitted
- 15 Dec 2008
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Homeopathic Drug Proving Using a Crossover Design
- ClinicalTrials.gov ID
- NCT00809263
- Acronym / sponsor ID
- HDPSCNM2008
- Conditions
- Healthy
- Keywords
- homeopathy, homeopathic drug proving, Document symptoms associated with administration of a homeopathic remedy.
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Integrative Medicine InstituteUniversity, hospital or other
- Collaborators
- Southwest College of Naturopathic Medicine, Heel GmbH
- Study start
- Oct 2009
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Dec 2008 (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.
In a homeopathic drug proving a homeopathically prepared substance is administered to healthy volunteers in order to produce the symptoms specific to that substance and thereby reveal its inherent curative powers. During a homeopathic drug proving the goal is to provoke temporary symptoms (or "artificial illness") associated with the homeopathic medication. These symptoms are then arranged to form a symptom pattern or 'remedy picture' which is specific to that particular homeopathic substance and provides the basis for a better understanding of the possible effects of that homeopathic remedy in patients.
Detailed description
The duration of these homeopathic drug provings are six week per subject (42 days). The central investigational tool of the homeopathic drug proving is the journal kept by each subject from DAY 1-35. The subject describes the symptoms they experience in their own words in the journal daily. During the 7 day run-in phase, the subject notes in their journal their current state of health, the daily rhythm of their life, and any other signs or symptoms that occur on a daily basis. This will also enhance familiarity with self-observation and the recording of signs and symptoms. After completion of this run-in phase an evaluation including journal check will occur on DAY 7. During the following 4 weeks (observation periods DAY 8-14, 22-28; wash-out period DAY 15-21 and 29 - 35) the subject documents all signs or symptoms that occur in his/her journal on a daily basis. During this period, subject interviews will take place on DAY 15, DAY 21. DAY 29 and DAY 36. During the 7 day follow up (post observation period, DAY 36-42) the subject will be contacted to check if any additional symptoms and/or adverse events occurred.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years and < 75 years
- General state of good health
- Continuation of the usual habits and patterns of daily living
- Written informed consent obtained and willingness to comply with the requirements of the study
Key exclusion criteria (8 listed)
- Any major life changes e.g. moving, getting married or divorced etc.
- Current or expected medical treatment or surgery during this homeopathic drug proving
- Surgery within the past four weeks prior to enrollment into the homeopathic drug proving
- Use of homeopathic medicines > 30 C or contraceptive pills in the month prior to enrollment into the homeopathic drug proving
- Alcohol or drug abuse
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 remedyHomeopathic remedy 12C potency, 10 drops TID X 7 days | Drug | – |
Primary outcome
Symptoms associated with the administration of homeopathic remedy to health subjects.
Time frame: 6 weeks per subject
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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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.
Steven Messer, ND principal investigator
Southwest College of Naturopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing homeopathic remedy in people with Healthy, run by Integrative Medicine Institute at 1 site in United States.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 13 Feb 2014. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Symptoms associated with the administration of homeopathic remedy to health subjects. (time frame: 6 weeks per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2014.