- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02773719
Biofields Therapy on Warts (MAGNETIK)
Effect of the Intervention of Biofields Therapy on Warts of the Hands and Feet in Adults: a Prospective, Randomized, Double-blind Trial
Traditionally, healers are willing to look after, two out of three French citizens have already appealed to them at least once during their lives. Many healers in good faith are exercising their magnetism as a "gift" often inherited from elders. Now, they create interest of doctors who do not hesitate in some cases to ensure their cooperation, to implicitly recognize their mysterious talents. Some serious studies have examined these practices: Several studies have been conducted on the influence of biofield therapies in pain, depression and fatigue in cancer disease. The investigators propose a study of the effect of magnetism on the wart disease whose cure is objectively assessable.
Sixty-two subjects in total would be included, comparing 2 proportions observed: the proportion of healing in the group treated with a "real" biofield therapist (recognized and affiliated to the National Group for Alternative Medicine in France) to the proportion of healing in the group treated with a "fake" biofield therapist (someone assessed as not having capacity to magnetize). The "fake" biofield therapist, placebo, has been trained to replicate gestures during a training validated by an independent recognized biofield therapist.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Caen, France
- CAEN University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Patients with common warts on hands or feet for over at least 3 months are eligible for the study. Patients fulfilling one or more of the following criteria will not be included: lack of informed consent prior to randomization, younger than 18 years or under judicial protection, treated with oral corticotherapy for more than 6 months, immunosuppressed or with history of transplant surgery, undergoing chemotherapy or suspected to have carcinomatous warts, or patients with infected warts, injured warts or already treated within 90 days with chemical processing, medical device, surgery or ever treated with biofield therapy.
Subject will be excluded from the study if its warts was treated by other treatment during protocol.
- ulcerated wart
- cancerous wart
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: True biofield therapist
Subject will have a 40 minutes therapy with a real biofield therapist to treat the wart
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Placebo Comparator: Fake biofield therapist
Subject will have a 40 minutes therapy with a fake biofield therapist to treat the wart
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disappearance of a common palmar or plantar wart
Time Frame: week 3
|
week 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disappearance of each other wart than the original one 3 weeks after the therapy
Time Frame: week 3
|
week 3
|
|
Percentage of reduction of each wart will be calculated using mean diameter of each wart at W0 and W3
Time Frame: week3
|
week3
|
|
Percentage of reduction of each wart will be calculated using mean diameter of each wart at W0 and W3
Time Frame: week 3
|
week 3
|
|
Disappearance of warts at 6 weeks
Time Frame: week 6
|
week 6
|
|
Level of belief in biofield therapy of the subject
Time Frame: week 6
|
week 0
|
week 6
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-163
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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