NCT04290143

Brief Summary

The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

February 17, 2020

Last Update Submit

February 26, 2020

Conditions

Balneology

Keywords

medical waterhealing waterplacebo

Outcome Measures

Primary Outcomes (12)

  • Number of participants who responded 'placebo,' to question 1

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    prior to treatment

  • Number of participants who responded 'colored healing water' to question 1

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    prior to treatment

  • Number of participants who responded ' could not tell' to question 1

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    prior to treatment

  • Number of participants who responded 'placebo,' to question 2

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    10 minutes after the beginning of treatment

  • Number of participants who responded 'colored healing water' to question 2

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    10 minutes after the beginning of treatment

  • Number of participants who responded ' could not tell' to question 2

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    10 minutes after the beginning of treatment

  • Number of participants who responded 'placebo,' to question 3

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    Immediately after the end of the treatment

  • Number of participants who responded 'colored healing water' to question 3

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    Immediately after the end of the treatment

  • Number of participants who responded ' could not tell' to question 3

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    Immediately after the end of the treatment

  • Number of participants who responded 'placebo,' to question 4

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    After taking a sower (within 15 minutes after the end of the treatment)

  • Number of participants who responded 'colored healing water' to question 4

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    After taking a sower (within 15 minutes after the end of the treatment)

  • Number of participants who responded ' could not tell' to question 4

    The measurement is performed by a questionnaire filled in accordingly by an investigator

    After taking a sower (within 15 minutes after the end of the treatment)

Study Arms (2)

Colored healing water

ACTIVE COMPARATOR

Colored medical water in a bath tub. A single 20 minutes-long treatment will be performed.

Other: Colored healing waterOther: Placebo treatment (colored tap water)

Placebo - Colored tap water

PLACEBO COMPARATOR

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.

Other: Colored healing waterOther: Placebo treatment (colored tap water)

Interventions

Colored healing waterOTHER

Patients will be treated with colored healing water for 20 minutes.

Colored healing waterPlacebo - Colored tap water
Placebo treatment (colored tap water)OTHER

Patients will be treated with colored tap water for 20 minutes.

Colored healing waterPlacebo - Colored tap water

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • willingness to participate in the study
  • age between 18-80 years

You may not qualify if:

  • patients physically unable to enter or exit the bath tub
  • autoimmune diseases
  • any kind of malignity
  • acute inflammation
  • infection
  • acute coronary syndrome or recent surgical interventions (6 month before enrollment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harkány Thermal Rehabilitation Centre

Harkány, Baranya, 7815, Hungary

Location

Katalin Dr Szendi

Pécs, Baranya, 7624, Hungary

Location

Related Publications (6)

  • 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.

    PMID: 23677421BACKGROUND

  • 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.

    PMID: 2494341BACKGROUND

  • 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.

    PMID: 30259887BACKGROUND

  • 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.

    PMID: 28849535BACKGROUND

  • 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.

    PMID: 28956169BACKGROUND

  • 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.

    PMID: 30734126BACKGROUND

Study Officials

  • Katalin Dr Szendi, MD, PhD

    University of Pecs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: double blind study for testing a placebo development method
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 28, 2020

Study Start

January 1, 2020

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Not necessary for the study purpose.

Locations

HU(2)