NCT04111653

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 urine following applications of thermal mud. The main objective is to highlight an increase in serum barium level of at least twice.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

September 30, 2019

Last Update Submit

July 8, 2020

Conditions

Mud Therapy

Keywords

mud therapynatural mineral waterbariumpoulticesskin transfer

Outcome Measures

Primary Outcomes (1)

  • Measurement of the plasma level of barium

    Plasma level of barium

    3 weeks

Secondary Outcomes (3)

  • Measurement of the urinary rate of barium

    3 weeks

  • Plasma level of barium exceeds the level deemed tolerable by INRS (French Institute for Research and Security)

    3 weeks

  • Number of patients who doubles the urinary and plasma level of barium

    3 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

Healthy volunteers

Other: Mud therapy

Interventions

Mud therapyOTHER

Application of sludge poultice

Single arm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • volunteers, healthy (without known and / or treated disease)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut du Thermalisme

Dax, 40100, France

RECRUITING

Related Publications (12)

  • Roques CF, Trèves R, Queneau P, Bontoux D. Avis de l'académie nationale de médecine relatif à l'évaluation des risques sanitaires liés à la présence de baryum dans des argiles constitutives des boues thermales et à l'absence de contrôle sanitaire des boues thermales. Bull Acad Ntle Méd., , 201: 13-38, 2017.

    BACKGROUND

  • Ainouche R, Tabone W, Bouvier CE, Renaud V. Usage thérapeutique (des boues thermales), panorama du thermalisme français en 2013. Bulletin de l'AFTH (Association Française des Techniques Hydrothermales), 2014, n° 25, Symposium Utilisation des boues en établissement thermal, Enghien les Bains, Novembre 2013, pp. 7-11

    BACKGROUND

  • Gomes C, Carretero MI, Pozo M, Maraver F, Cantista P et al. Peloids and pelotherapy : historical evolution, classification and glossary. Applied clay science 75-76:28-38, 2013.

    BACKGROUND

  • Liu H, Zeng C, Gao SG, Yang T, Luo W, Li YS, Xiong YL, Sun JP, Lei GH. The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2013 Oct;41(5):1418-25. doi: 10.1177/0300060513488509. Epub 2013 Sep 5.

    PMID: 24008567BACKGROUND

  • Roques CF. Mud Therapy. Data of clinical evidence. Balnea 10:57-62, 2015.

    BACKGROUND

  • Xiang J, Wu D, Li J. Clinical Efficacy of Mudpack Therapy in Treating Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Studies. Am J Phys Med Rehabil. 2016 Feb;95(2):121-31. doi: 10.1097/PHM.0000000000000354.

    PMID: 26203645BACKGROUND

  • Roques CF, Queneau P. [SPA therapy for pain of patients with chronic low back pain, knee osteo-arthritis and fibromyalgia]. Bull Acad Natl Med. 2016 Mar;200(3):575-86; discussion 586-7. French.

    PMID: 28644605BACKGROUND

  • World Health Organization (WHO) - 2001 - IPCS (International Programme on Chemical Safety) - Concise international chemical assessment document 33 - barium and barium compounds. 57 pp

    BACKGROUND

  • Conseil canadien des Ministres de l'environnement - Recommandations canadiennes pour la qualité des sols - environnement et santé humaine. Le baryum. Feuillet d'information 2013, 1 doc 11 pp

    BACKGROUND

  • Kravchenko J, Darrah TH, Miller RK, Lyerly HK, Vengosh A. A review of the health impacts of barium from natural and anthropogenic exposure. Environ Geochem Health. 2014 Aug;36(4):797-814. doi: 10.1007/s10653-014-9622-7. Epub 2014 May 21.

    PMID: 24844320BACKGROUND

  • INRS - base de données de fiches toxicologiques. Baryum et composés. Fiche toxicologique complète n°125. 1 doc 12 pp, 2012

    BACKGROUND

  • Ding C, Pan Y, Zhang A, Zhu C, Liu D, Xu G, Zheng Y, Yan H. [Distribution of rubidium, cesium, beryllium, strontium, and barium in blood and urine in general Chinese population]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2015 Dec;33(12):894-9. doi: 10.3760/cma.j.issn.1001-9391.2015.12.004. Chinese.

    PMID: 27122328BACKGROUND

MeSH Terms

Interventions

Mud Therapy

Intervention Hierarchy (Ancestors)

BalneologyTherapeutics

Study Officials

  • Frédéric Bauduer, Pr

    Institut du thermalisme

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerome Dimet, PhD

CONTACT

5.58.05.29.30jerome.dimet@ght40.fr

Anne-Hélène Boivin

CONTACT

5.58.05.29.09anne-helene.boivin@ght40.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 1, 2019

Study Start

January 13, 2020

Primary Completion

July 30, 2020

Study Completion

September 30, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)