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Biofields Therapy on Warts (MAGNETIK)

Primary Purpose

Wart, Energy Medecine, Magnetism

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
True Biofield therapy
Fake Biofield therapy
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wart

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Caen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

True biofield therapist

Fake biofield therapist

Arm Description

Subject will have a 40 minutes therapy with a real biofield therapist to treat the wart

Subject will have a 40 minutes therapy with a fake biofield therapist to treat the wart

Outcomes

Primary Outcome Measures

disappearance of a common palmar or plantar wart

Secondary Outcome Measures

disappearance of each other wart than the original one 3 weeks after the therapy
Percentage of reduction of each wart will be calculated using mean diameter of each wart at W0 and W3
Percentage of reduction of each wart will be calculated using mean diameter of each wart at W0 and W3
Disappearance of warts at 6 weeks
Level of belief in biofield therapy of the subject
week 0

Full Information

First Posted
April 22, 2016
Last Updated
January 31, 2019
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02773719
Brief Title
Biofields Therapy on Warts
Acronym
MAGNETIK
Official Title
Effect of the Intervention of Biofields Therapy on Warts of the Hands and Feet in Adults: a Prospective, Randomized, Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wart, Energy Medecine, Magnetism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
True biofield therapist
Arm Type
Experimental
Arm Description
Subject will have a 40 minutes therapy with a real biofield therapist to treat the wart
Arm Title
Fake biofield therapist
Arm Type
Placebo Comparator
Arm Description
Subject will have a 40 minutes therapy with a fake biofield therapist to treat the wart
Intervention Type
Other
Intervention Name(s)
True Biofield therapy
Intervention Type
Other
Intervention Name(s)
Fake Biofield therapy
Primary Outcome Measure Information:
Title
disappearance of a common palmar or plantar wart
Time Frame
week 3
Secondary Outcome Measure Information:
Title
disappearance of each other wart than the original one 3 weeks after the therapy
Time Frame
week 3
Title
Percentage of reduction of each wart will be calculated using mean diameter of each wart at W0 and W3
Time Frame
week3
Title
Percentage of reduction of each wart will be calculated using mean diameter of each wart at W0 and W3
Time Frame
week 3
Title
Disappearance of warts at 6 weeks
Time Frame
week 6
Title
Level of belief in biofield therapy of the subject
Description
week 0
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28592299
Citation
Gaillard C, Allain L, Legros H, Brucato S, Desgue Y, Rouillon C, Peyro-Saint-Paul L, Dompmartin A. Real versus sham proximal biofield therapy in the treatment of warts of the hands and feet in adults: study protocol for a randomized controlled trial (MAGNETIK study). Trials. 2017 Jun 7;18(1):263. doi: 10.1186/s13063-017-1994-4.
Results Reference
derived

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Biofields Therapy on Warts

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