Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
174 participants
INTERVENTIONAL
2020-01-01
2020-02-07
Brief Summary
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Detailed Description
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Methods: Both medical water and tap water will be colored. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water. The patients will be divided into two groups, colored healing water and placebo group. A single 20 minutes-long treatment will be performed in bath tubs. Considering the healing waters odor, the treatment will be given in the same room. Patients will be asked to tell whether they are treated with colored healing water or placebo or could not tell. Questions will be asked before the treatment, 10 minutes after the beginning of the treatment, immediately after the end of the treatment and after shower. The study will be performed in a double blind setup. Patients will be scored, one point for each correct answer.
Target patient number:174
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Colored healing water
Colored medical water in a bath tub. A single 20 minutes-long treatment will be performed.
Colored healing water
Patients will be treated with colored healing water for 20 minutes.
Placebo treatment (colored tap water)
Patients will be treated with colored tap water for 20 minutes.
Placebo - Colored tap water
Colored tap water. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water. A single 20 minutes-long treatment will be performed.
Colored healing water
Patients will be treated with colored healing water for 20 minutes.
Placebo treatment (colored tap water)
Patients will be treated with colored tap water for 20 minutes.
Interventions
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Colored healing water
Patients will be treated with colored healing water for 20 minutes.
Placebo treatment (colored tap water)
Patients will be treated with colored tap water for 20 minutes.
Eligibility Criteria
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Inclusion Criteria
* age between 18-80 years
Exclusion Criteria
* autoimmune diseases
* any kind of malignity
* acute inflammation
* infection
* acute coronary syndrome or recent surgical interventions (6 month before enrollment)
18 Years
80 Years
ALL
Yes
Sponsors
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Harkány Spa Hospital, Harkány, Hungary
UNKNOWN
National Research, Development and Innovation Office, Budapest, Hungary
UNKNOWN
University of Pecs
OTHER
Responsible Party
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Principal Investigators
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Katalin Dr Szendi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pecs
Locations
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Harkány Thermal Rehabilitation Centre
Harkány, Baranya, Hungary
Katalin Dr Szendi
Pécs, Baranya, Hungary
Countries
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References
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Bender T, Balint G, Prohaszka Z, Geher P, Tefner IK. Evidence-based hydro- and balneotherapy in Hungary--a systematic review and meta-analysis. Int J Biometeorol. 2014 Apr;58(3):311-23. doi: 10.1007/s00484-013-0667-6. Epub 2013 May 16.
Szucs L, Ratko I, Lesko T, Szoor I, Genti G, Balint G. Double-blind trial on the effectiveness of the Puspokladany thermal water on arthrosis of the knee-joints. J R Soc Health. 1989 Feb;109(1):7-9. doi: 10.1177/146642408910900104. No abstract available.
Matsumoto S. Evaluation of the Role of Balneotherapy in Rehabilitation Medicine. J Nippon Med Sch. 2018;85(4):196-203. doi: 10.1272/jnms.JNMS.2018_85-30.
Morer C, Roques CF, Francon A, Forestier R, Maraver F. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials. Int J Biometeorol. 2017 Dec;61(12):2159-2173. doi: 10.1007/s00484-017-1421-2. Epub 2017 Aug 28.
Hanzel A, Horvat K, Molics B, Berenyi K, Nemeth B, Szendi K, Varga C. Clinical improvement of patients with osteoarthritis using thermal mineral water at Szigetvar Spa-results of a randomised double-blind controlled study. Int J Biometeorol. 2018 Feb;62(2):253-259. doi: 10.1007/s00484-017-1446-6. Epub 2017 Sep 27.
Hanzel A, Berenyi K, Horvath K, Szendi K, Nemeth B, Varga C. Evidence for the therapeutic effect of the organic content in Szigetvar thermal water on osteoarthritis: a double-blind, randomized, controlled clinical trial. Int J Biometeorol. 2019 Apr;63(4):449-458. doi: 10.1007/s00484-019-01676-3. Epub 2019 Feb 7.
Other Identifiers
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OTKA_131531_PLACEBO
Identifier Type: -
Identifier Source: org_study_id