HealthyNCT02018341
The Homeogenomic Trial
A study testing homeopathic remedy in 30C potency in people with Healthy, run by University of Washington at 1 site in United States.
Trial summary
A randomized double-blind placebo controlled homeopathic pathogenetic trial (HPT) will be carried out on 30 healthy adult volunteers. The remedy used for the proving will be administered in a potency of 30C. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- homeopathic remedy in 30C potency
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Read and Speak English
Who cannot join
- Acute illness in last 7 days
- Chronic illness requiring daily medication
- Use of homeopathic remedy within 4 weeks
- Use of homeopathic remedy of 200C potency in past 2 months
- Women who are pregnant or breastfeeding an infant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-blind Placebo Controlled Homeopathic Pathogenetic Trial (HPT) on Healthy Volunteers Proving XX in the Potency of 30C, "The Homeogenomic Trial"
A randomized double-blind placebo controlled homeopathic pathogenetic trial (HPT) will be carried out on 30 healthy adult volunteers. The remedy used for the proving will be administered in a potency of 30C. The remedy being used is a common homeopathic remedy commercially available in the US, but the exact remedy is not disclosed to participants.The purpose of the proving is twofold: 1) to determine if there is a difference in symptoms between those receiving an active versus placebo medicine, and 2) to see if there is a difference in gene expression between those who receive the homeopathic remedy or placebo. It is hypothesized that participants receiving the active medication will have more symptoms characteristic of the remedy and have specific patterns of gene expression in whole blood that are different from those in placebo recipients. Participants will record symptoms in a diary for 3 days prior to administration of study medications, during 3 day of its administration and for 3 days following completion of the study medication. Blood will be drawn for gene expression studies on the day that the study medication is started and again after taking the study medication for approximately 48 hours. An additional, optional blood draw for possible future analysis of gene expression will be done at the end of the study period.
- Conditions
- Healthy
- Being tested
- homeopathic remedy in 30C potency, Placebo
- Keywords
- Assessment of biologic activity of a homeopathic remedy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
homeopathic remedy in 30C potencyOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| homeopathic remedy in 30C potency | Experimental | 5 lactose globules containing a commonly used homeopathic remedy in the potency of 30C will be administered twice daily for 3 days Receives: Other: homeopathic remedy in 30C potency |
| placebo | Placebo comparator | 5 lactose globules without any homeopathic remedy will be administered twice daily for 3 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristic symptoms
Symptoms that occur in participants that are characteristic of the homeopathic remedy being used in the study
Measured: 6 days
gene expression
Changes in whole blood gene expression from just prior to beginning study medication until 48 hours after beginning study medication
Measured: 2 days
Secondary outcomes (1)
gene expression in sensitive provers
gene expression in participants receiving active study medication and who are classified as sensitive provers based on review of their symptoms will be compared to gene expression in placebo recipients.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: Funding withdrawn
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.
- More trials run by University of WashingtonThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Taylor, University of Washington
- Investigators
- James A Taylor, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018341
- Sponsor's protocol ID
- 44817
- Status last verified
- Dec 2013
- First submitted
- 20 Jun 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo Controlled Homeopathic Pathogenetic Trial (HPT) on Healthy Volunteers Proving XX in the Potency of 30C, "The Homeogenomic Trial"
- ClinicalTrials.gov ID
- NCT02018341
- Acronym / sponsor ID
- 44817
- Conditions
- Healthy
- Keywords
- Assessment of biologic activity of a homeopathic remedy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 23 Dec 2013 (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.
A randomized double-blind placebo controlled homeopathic pathogenetic trial (HPT) will be carried out on 30 healthy adult volunteers. The remedy used for the proving will be administered in a potency of 30C. The remedy being used is a common homeopathic remedy commercially available in the US, but the exact remedy is not disclosed to participants.The purpose of the proving is twofold: 1) to determine if there is a difference in symptoms between those receiving an active versus placebo medicine, and 2) to see if there is a difference in gene expression between those who receive the homeopathic remedy or placebo. It is hypothesized that participants receiving the active medication will have more symptoms characteristic of the remedy and have specific patterns of gene expression in whole blood that are different from those in placebo recipients. Participants will record symptoms in a diary for 3 days prior to administration of study medications, during 3 day of its administration and for 3 days following completion of the study medication. Blood will be drawn for gene expression studies on the day that the study medication is started and again after taking the study medication for approximately 48 hours. An additional, optional blood draw for possible future analysis of gene expression will be done at the end of the study period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| homeopathic remedy in 30C potency | Experimental | Other: homeopathic remedy in 30C potency5 lactose globules containing a commonly used homeopathic remedy in the potency of 30C will be administered twice daily for 3 days |
| placebo | Placebo comparator | Other: Placebo5 lactose globules without any homeopathic remedy will be administered twice daily for 3 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Read and Speak English
Key exclusion criteria (5 listed)
- Acute illness in last 7 days
- Chronic illness requiring daily medication
- Use of homeopathic remedy within 4 weeks
- Use of homeopathic remedy of 200C potency in past 2 months
- Women who are pregnant or breastfeeding an infant
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 remedy in 30C potency | Other | homeopathic remedy in 30C potency |
| Placebo | Other | placebo |
Primary outcome
Characteristic symptoms
Time frame: 6 days
Symptoms that occur in participants that are characteristic of the homeopathic remedy being used in the study
gene expression
Time frame: 2 days
Changes in whole blood gene expression from just prior to beginning study medication until 48 hours after beginning study medication
1 secondary outcome
gene expression in sensitive provers
Time frame: 2 days
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 23 Dec 2013.
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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.
James A Taylor, MD principal investigator
University of Washington
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 30C potency in people with Healthy, run by University of Washington 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 1 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: withdrawn, as of the sponsor's last update on 23 Dec 2013. 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. 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.
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?
Characteristic symptoms (time frame: 6 days). The study lists 2 primary outcomes in all. 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 23 Dec 2013.