BalneologyNCT04290143
Placebo Development and Validation for Healing Water
A study testing Colored healing water in people with Balneology, run by University of Pecs at 2 sites in Hungary.
Trial summary
The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Balneology
- What is being tested?
- Colored healing water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 2 sitesHungary
- Study dates
- 1 Jan 2020to 7 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willingness to participate in the study
- age between 18-80 years
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Harkány Thermal Rehabilitation Centre
Harkány, Baranya, 7815
Katalin Dr Szendi
Pécs, Baranya, 7624
About this study
Official title: Introducing a New and Validated Placebo Development Method to Healing Water Based Rehabilitation Research
The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
Read the detailed description
Introduction: The beneficial health effects of healing waters have been reported by numerous studies. However, the lack of proper placebo substance makes the "medication-like" investigation of healing waters difficult. The investigators aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
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
- Balneology
- Being tested
- Colored healing water, Placebo treatment (colored tap water)
- Keywords
- medical water, healing water, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colored healing waterOther
Patients will be treated with colored healing water for 20 minutes.
Placebo treatment (colored tap water)Other
Patients will be treated with colored tap water for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Colored healing water | Active comparator | Colored medical water in a bath tub. A single 20 minutes-long treatment will be performed. Receives: Other: Colored healing water; Other: 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. Receives: Other: Colored healing water; Other: Placebo treatment (colored tap water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who responded 'placebo,' to question 1
The measurement is performed by a questionnaire filled in accordingly by an investigator
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After taking a sower (within 15 minutes after the end of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Jan 2020
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BalneologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind study for testing a placebo development method
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Collaborators
- Harkány Spa Hospital, Harkány, Hungary, National Research, Development and Innovation Office, Hungary
- Responsible party
- Sponsor
- Investigators
- Katalin Dr Szendi, MD, PhD, Principal investigator, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290143
- Sponsor's protocol ID
- OTKA_131531_PLACEBO
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not necessary for the study purpose.
Publications
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.
PubMed 23677421Szucs 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.
PubMed 2494341Matsumoto 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.
PubMed 30259887Morer 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.
PubMed 28849535Hanzel 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.
PubMed 28956169Hanzel 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.
PubMed 30734126
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing a New and Validated Placebo Development Method to Healing Water Based Rehabilitation Research
- ClinicalTrials.gov ID
- NCT04290143
- Acronym / sponsor ID
- OTKA_131531_PLACEBO
- Conditions
- Balneology
- Keywords
- medical water, healing water, placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Collaborators
- Harkány Spa Hospital, Harkány, Hungary, National Research, Development and Innovation Office, Hungary
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
Detailed description
Introduction: The beneficial health effects of healing waters have been reported by numerous studies. However, the lack of proper placebo substance makes the "medication-like" investigation of healing waters difficult. The investigators aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind study for testing a placebo development method
| Arm | Type | Receives |
|---|---|---|
| Colored healing water | Active comparator | Other: Colored healing water, Other: Placebo treatment (colored tap water)Colored medical water in a bath tub. A single 20 minutes-long treatment will be performed. |
| Placebo - Colored tap water | Placebo comparator | Other: Colored healing water, Other: Placebo treatment (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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- willingness to participate in the study
- age between 18-80 years
Key exclusion criteria (6 listed)
- patients physically unable to enter or exit the bath tub
- autoimmune diseases
- any kind of malignity
- acute inflammation
- infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colored healing waterPatients will be treated with colored healing water for 20 minutes. | Other | Colored healing water, Placebo - Colored tap water |
| Placebo treatment (colored tap water)Patients will be treated with colored tap water for 20 minutes. | Other | Colored healing water, Placebo - Colored tap water |
Primary outcome
Number of participants who responded 'placebo,' to question 1
Time frame: prior to treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'colored healing water' to question 1
Time frame: prior to treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded ' could not tell' to question 1
Time frame: prior to treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'placebo,' to question 2
Time frame: 10 minutes after the beginning of treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'colored healing water' to question 2
Time frame: 10 minutes after the beginning of treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded ' could not tell' to question 2
Time frame: 10 minutes after the beginning of treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'placebo,' to question 3
Time frame: Immediately after the end of the treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'colored healing water' to question 3
Time frame: Immediately after the end of the treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded ' could not tell' to question 3
Time frame: Immediately after the end of the treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'placebo,' to question 4
Time frame: After taking a sower (within 15 minutes after the end of the treatment)
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'colored healing water' to question 4
Time frame: After taking a sower (within 15 minutes after the end of the treatment)
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded ' could not tell' to question 4
Time frame: After taking a sower (within 15 minutes after the end of the treatment)
The measurement is performed by a questionnaire filled in accordingly by an investigator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Background: PubMed 23677421Bender 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.
- Background: PubMed 2494341Szucs 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.
- Background: PubMed 30259887Matsumoto 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.
- Background: PubMed 28849535Morer 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.
- Background: PubMed 28956169Hanzel 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.
- Background: PubMed 30734126Hanzel 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.
- Individual participant dataSharing planned: No. Not necessary for the study purpose.
Related trials for Balneology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katalin Dr Szendi, MD, PhD principal investigator
University of Pecs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colored healing water in people with Balneology, run by University of Pecs at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who responded 'placebo,' to question 1 (time frame: prior to treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290143, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.