Status:
UNKNOWN
Exploration of the Transfer of Barium From Thermal Mud
Lead Sponsor:
Association Francaise pour la Recherche Thermale
Conditions:
Mud Therapy
Eligibility:
All Genders
18-30 years
Phase:
NA
Brief Summary
It involves conducting a clinical study on a population of healthy volunteers (age between 18 and 30 years) without direct benefit for the subject to explore a transfer of barium in the blood and urin...
Detailed Description
The presence of barium in thermal clays was noted by the ARS (french administration) who interviewed the Directorate General of Health (DGS); the latter seized the National Academy of Medicine (June 2...
Eligibility Criteria
Inclusion
- volunteers, healthy (without known and / or treated disease)
- 18 to 30 years old,
- men and women, who can give their informed consent, presenting the elements of cutaneous and general tolerance of sludge applications
- patient affiliated to a social security scheme
Exclusion
- subject who can not give informed consent
- pregnant woman ; woman of childbearing years not wishing to have contraception available for the duration of the trial
- subject to a legal protection measure or a judicial review, subject having a known allergy to a heavy metal, a BMI greater than 30
- a characterized contact eczema, an active dermatosis, an acute affection, a disorder of the cutaneous sensitivity, an intolerance to the heat
- heart, kidney or lung disease that may be decompensated with the use of hot products
- a progressive disease (inflammatory, infectious or tumoral) potentially liable to worsen with the application of thermal physical agents
Key Trial Info
Start Date :
January 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04111653
Start Date
January 13 2020
End Date
September 30 2020
Last Update
July 9 2020
Active Locations (1)
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1
Institut du Thermalisme
Dax, France, 40100