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Rheumatoid ArthritisNCT04275206

The Anti-inflammatory Effects of Harkány Medicinal Water

A study testing Harkány medicinal water in people with Rheumatoid Arthritis and Psoriasis, run by University of Pecs at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study aims to provide evidence on the effectiveness of Harkány medicinal water in psoriatic and rheumatoid arthritis patients using subjective and objective methods. It is a cross-over study, so first half of patients will receive medicinal water, the other half will receive tap water treatment, and after 6 months… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis, Psoriasis
What is being tested?
Harkány medicinal water
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
1 siteHungary
Study dates
1 Jun 2020to 30 Nov 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • signed consent statement
  • over 18 years of age
  • lack of underlying renal disease (GFR >60 mL/min/1.73m2)
  • lack of severe inflammation (WBC <20.000 G/l; CRP <50 mg/l; WE <40 mm/h)
  • psoriasis vulgaris with skin lesions
  • mild and inactive RA

Who cannot join

  • having received any kind of balneotherapy within 1 year before admission
  • discontinuance of rehabilitation
  • withdrawal of consent
  • clinically significant difference in severity of the patient's condition on 1st or 2nd admission
  • severe RA
  • patients suffering from cancer
Show all 13Show fewer
  • patients suffering from inflammatory bowel disease
  • patients underwent stroke within 1 year
  • severe hypercholesterolemia
  • severe diabetes
  • patients with renal insufficiency
  • patients receiving any kind biological therapy
  • patients whose medication has changed during the study period or one month prior to the second treatment session

Trial locations and contacts

1 site in 1 country.

Katalin Dr Szendi, MD, PhD contact

+3672536396

szkata82@yahoo.co.uk

Balázs Dr Németh, MD, PhD contact

+3672536037

nem_bal2@hotmail.com

Hungary1 site, 1 recruiting

  • Katalin Dr Szendi

    Pécs, Baranya, 7624

    Katalin Dr Szendi, MD, PhD, +3672536396, szkata82@yahoo.co.uk

    Balázs Dr Németh, MD, PhD, +3672536037, nem_bal2@hotmail.com

    Recruiting

Other trials in Hungary

About this study

The study aims to provide evidence on the effectiveness of Harkány medicinal water in psoriatic and rheumatoid arthritis patients using subjective and objective methods. It is a cross-over study, so first half of patients will receive medicinal water, the other half will receive tap water treatment, and after 6 months treatments will be repeated, but patients will receive the other type of water.

Read the detailed description

Several studies have shown that medicinal waters are highly effective in the treatment of many diseases. Existing clinical trials were unable to provide scientific evidence by using the highest international standards to justify the efficiency of thermal waters. Harkány medicinal water has been used for rheumatic, skin and locomotor diseases for more than 100 years. Its beneficial effects are indisputable. However, to introduce these effects, internationally high-level scientific methods and investigations are needed.

Psoriasis is among the most common dermatological diseases worldwide. Its significance is emphasized by adverse effects on quality of life, caused by chronic pain, physical and psychical disability due to psoriatic plaques. Former studies revealed an increased risk of inflammatory bowel disease, cardiovascular disease and certain types of cancer. Moreover, excessive oxidative stress can be responsible for the onset of psoriasis complications.

Rheumatoid arthritis (RA) is an autoimmune disease responsible for significant morbidity, characterized by articular inflammation. Oxidative stress is a key marker for determining pathophysiology of patients with RA.

The pathophysiological link between these conditions is the presence of excessive oxidative stress.

Subjective methods will include questionnaires, objective markers of disease severity will include the measurement of biomarkers from blood samples.

Being tested
Harkány medicinal water, Tap water (placebo control)
Keywords
medicinal water,inflammation,biomarker,inflammatory disease
Medical subject headings
Arthritis, Rheumatoid, Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Harkány medicinal waterOther

    The aim is to prove the effectiveness of Harkány medicinal water on patients suffering from psoriasis and rheumatoid arthritis. The control group is treated with tap water.

  • Tap water (placebo control)Other

    The control group is treated with tap water.

Study groups in NCT04275206
Study groupRoleWhat they receive
Medicinal water treated groupExperimental3-week-long inward rehabilitation, in a bath tab, for 30 min, 5 days a week. (After 6 months treatments will be repeated in tap water.)
Receives: Other: Harkány medicinal water
Tap water treated groupPlacebo comparator3-week-long inward rehabilitation, in a bath tab, for 30 min, 5 days a week. (After 6 months treatments will be repeated in medicinal water.)
Receives: Other: Tap water (placebo control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dermatology Life Quality Index (DLQI)

    Self reported questionnaire is to measure how much the skin problem has affected the patient's life over the last week.

    The scoring of each question is as follows:

    Very much - scored 3; A lot - scored 2; A little - scored 1; Not at all - scored 0; Not relevant - scored 0; Question 7, 'prevented work or studying' - scored 3.

    The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

    Measured: baseline (on admission)

  2. Functional Independence Measure (FIM)

    It is an 18-item measurement tool that explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention.

    Each item is scored 1-7. No Helper: 7. Complete Independence (Timely, Safety); 6. Modified Independence (Device)

    Helper - Modified Dependence: 5. Supervision (Subject = 100%); 4. Minimal Assistance (Subject = 75% or more); 3. Moderate Assistance (Subject = 50% or more)

    Helper - Complete Dependence: 2. Maximal Assistance (Subject = 25% or more); 1. Total Assistance or not Testable (Subject less than 25%)

    Measured: baseline (on admission)

  3. SF-36

    This questionnaire contains 36 items that assess patients' health status and its impact on their lives. SF-36 is a structured, self-report questionnaire that a patient can complete with little or no counseling from an interviewer. Answers to the questions yield eight domains [scored from 0 (low) to 100 (high)] and two summary physical and mental component scores (PCS and MCS).

    Measured: baseline (on admission)

  4. Patient Uncertainty Questionnaire-Rheumatology (PUQ-R)

    Questions about issues related to arthritis. Each item is scored 1-4 (1 = very uncertain, 4 = very certain). Patients answer each question according to how certain or uncertain they are about each issues.

    Measured: baseline (on admission)

  5. Psoriasis Area Severity Index (PASI)

    It is used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. For each body section (head, arms, trunk and legs) the percent of area of skin involved and the severity of three clinical signs (erythema, induration and desquamation) on a scale from 0 to 4 (from none to maximum) are to be specified.

    Measured: baseline (on admission)

  6. Disease Activity Score Calculator for Rheumatoid Arthritis (DAS 28)

    It makes an objective, reproducible and comparable assessment of the rheumatoid arthritis activity. It takes into account the following items:

    TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). ESR: The Erythrocyte Sedimentation Rate (in mm/h). GH: The patient global health assessment (from 0=best to 100=worst).

    The 28 tender or swollen joint scores target the same joints (shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees).

    Measured: baseline (on admission)

  7. White blood cell count (Routine laboratory parameter)

    Aspecific test for monitoring inflammation.

    Measured: baseline (on admission)

  8. Haemoglobin (Routine laboratory parameter)

    Part of general laboratory test.

    Measured: baseline (on admission)

  9. Haematocrit (Routine laboratory parameter)

    Part of general laboratory test.

    Measured: baseline (on admission)

  10. WE (Routine laboratory parameter)

    Aspecific test for monitoring inflammation.

    Measured: baseline (on admission)

  11. Creatinine /eGFR/ (Routine laboratory parameter)

    General kidney function.

    Measured: baseline (on admission)

  12. Uric acid (Routine laboratory parameter)

    Aspecific marker of antioxidant system.

    Measured: baseline (on admission)

  13. High sensitivity C-reactive protein (hs-CRP)

    hs-CRP is an aspecific inflammatory parameter, involved in most risk evaluation systems and generally used in clinical practice.

    Measured: baseline (on admission)

  14. Asymmetric dimethylarginine (ADMA)

    ADMA is considered as a marker and mediator of oxidative stress and an indicator of vascular well-being.

    Measured: baseline (on admission)

  15. Total antioxidant capacity (TAC)

    TAC is an easily feasible, widely used method, indirect marker of oxidative stress.

    Measured: baseline (on admission)

  16. Malondialdehyde (MDA)

    MDA is a well-known biomarker of oxidative stress. It is also a sensitive marker of inflammation in patients with RA.

    Measured: baseline (on admission)

Secondary outcomes (14)

  1. Dermatology Life Quality Index (DLQI)

    Self reported questionnaire is to measure how much the skin problem has affected the patient's life over the last week.

    The scoring of each question is as follows:

    Very much - scored 3; A lot - scored 2; A little - scored 1; Not at all - scored 0; Not relevant - scored 0; Question 7, 'prevented work or studying' - scored 3.

    The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

    Measured: 3 weeks (before discharge)

  2. Functional Independence Measure (FIM)

    It is an 18-item measurement tool that explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention.

    Each item is scored 1-7. No Helper: 7. Complete Independence (Timely, Safety); 6. Modified Independence (Device)

    Helper - Modified Dependence: 5. Supervision (Subject = 100%); 4. Minimal Assistance (Subject = 75% or more); 3. Moderate Assistance (Subject = 50% or more)

    Helper - Complete Dependence: 2. Maximal Assistance (Subject = 25% or more); 1. Total Assistance or not Testable (Subject less than 25%)

    Measured: 3 weeks (before discharge)

  3. SF-36

    This questionnaire contains 36 items that assess patients' health status and its impact on their lives. SF-36 is a structured, self-report questionnaire that a patient can complete with little or no counseling from an interviewer. Answers to the questions yield eight domains [scored from 0 (low) to 100 (high)] and two summary physical and mental component scores (PCS and MCS).

    Measured: 3 weeks (before discharge)

  4. Patient Uncertainty Questionnaire-Rheumatology (PUQ-R)

    Questions about issues related to arthritis. Each item is scored 1-4 (1 = very uncertain, 4 = very certain). Patients answer each question according to how certain or uncertain they are about each issues.

    Measured: 3 weeks (before discharge)

  5. Psoriasis Area Severity Index (PASI)

    It is used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. For each body section (head, arms, trunk and legs) the percent of area of skin involved and the severity of three clinical signs (erythema, induration and desquamation) on a scale from 0 to 4 (from none to maximum) are to be specified.

    Measured: 3 weeks (before discharge)

  6. Disease Activity Score Calculator for Rheumatoid Arthritis (DAS 28)

    It makes an objective, reproducible and comparable assessment of the rheumatoid arthritis activity. It takes into account the following items:

    TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). ESR: The Erythrocyte Sedimentation Rate (in mm/h). GH: The patient global health assessment (from 0=best to 100=worst).

    The 28 tender or swollen joint scores target the same joints (shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees).

    Measured: 3 weeks (before discharge)

  7. White blood cell count (Routine laboratory parameter)

    Aspecific test for monitoring inflammation.

    Measured: 3 weeks (before discharge)

  8. WE (Routine laboratory parameter)

    Aspecific test for monitoring inflammation.

    Measured: 3 weeks (before discharge)

  9. Creatinine /eGFR/ (Routine laboratory parameter)

    General kidney function.

    Measured: 3 weeks (before discharge)

  10. Uric acid (Routine laboratory parameter)

    Aspecific marker of antioxidant system.

    Measured: 3 weeks (before discharge)

  11. High sensitivity C-reactive protein (hs-CRP)

    hs-CRP is an aspecific inflammatory parameter, involved in most risk evaluation systems and generally used in clinical practice.

    Measured: 3 weeks (before discharge)

  12. Asymmetric dimethylarginine (ADMA)

    ADMA is considered as a marker and mediator of oxidative stress and an indicator of vascular well-being.

    Measured: 3 weeks (before discharge)

  13. Total antioxidant capacity (TAC)

    TAC is an easily feasible, widely used method, indirect marker of oxidative stress.

    Measured: 3 weeks (before discharge)

  14. Malondialdehyde (MDA)

    MDA is a well-known biomarker of oxidative stress. It is also a sensitive marker of inflammation in patients with RA.

    Measured: 3 weeks (before discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2020
  2. Study start1 Jun 2020 (estimated)
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Psoriasis / RA (t=0) Control (t=1) ---\> (t=3) Medicinal water (t=4) (t=0) Medicinal water (t=1) ---\> (t=3) Control (t=4) After 6 months, treatments will be repeated, but transposed, the previously control patients will receive medicinal water treatment, and tap water treatment will be performed on the previously treated group.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04275206
Sponsor's protocol ID
131531
Status last verified
Jun 2020
First submitted
14 Feb 2020
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

  • Szendi K, Gerencsér G, Murányi E, Varga Cs. Mutagenic activity of peloids in the Salmonella Ames test. Applied Clay Science 55: 70-74, 2012.

  • Gerencsér G, Murányi E, Szendi K, Varga Cs. Ecotoxicological studies on Hungarian peloids (medicinal muds). Applied Clay Science 50(1): 47-50, 2010.

  • Varga C, Laszlo M, Gerencser G, Gyongyi Z, Szendi K. Natural UV-protective organic matter in thermal water. J Photochem Photobiol B. 2015 Mar;144:8-10. doi: 10.1016/j.jphotobiol.2015.01.007. Epub 2015 Jan 22.

    PubMed 25662041

  • Gerencser G, Szendi K, Berenyi K, Varga C. Can the use of medical muds cause genotoxicity in eukaryotic cells? A trial using comet assay. Environ Geochem Health. 2015 Feb;37(1):63-70. doi: 10.1007/s10653-014-9630-7. Epub 2014 Jul 26.

    PubMed 25063339

  • Peter I, Jagicza A, Ajtay Z, Boncz I, Kiss I, Szendi K, Kustan P, Nemeth B. Balneotherapy in Psoriasis Rehabilitation. In Vivo. 2017 Nov-Dec;31(6):1163-1168. doi: 10.21873/invivo.11184.

    PubMed 29102940

  • Szendi K, Gyöngyi Z, Kontár Zs, Gerencsér G, Berényi K, Hanzel A, Fekete J, Kovács A, Varga Cs. Mutagenicity and Phthalate Level of Bottled Water Under Different Storage Conditions. Exposure and Health 10(1): 51-60, 2018.

  • 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.

    PubMed 28956169

  • 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.

    PubMed 30734126

  • Nemeth B, Ajtay Z, Hejjel L, Ferenci T, Abram Z, Muranyi E, Kiss I. The issue of plasma asymmetric dimethylarginine reference range - A systematic review and meta-analysis. PLoS One. 2017 May 11;12(5):e0177493. doi: 10.1371/journal.pone.0177493. eCollection 2017.

    PubMed 28494019

  • Nemeth B, Kustan P, Nemeth A, Lenkey Z, Cziraki A, Kiss I, Sulyok E, Ajtay Z. [Asymmetric dimethylarginine: predictor of cardiovascular diseases?]. Orv Hetil. 2016 Mar 27;157(13):483-7. doi: 10.1556/650.2016.30396. Hungarian.

    PubMed 26996894

  • Peter I, Jagicza A, Ajtay Z, Kiss I, Nemeth B. [Psoriasis and oxidative stress]. Orv Hetil. 2016 Nov;157(45):1781-1785. doi: 10.1556/650.2016.30589. Hungarian.

    PubMed 27817235

  • Kalavacherla US, Ishaq M, Rao UR, Sachindranath A, Hepsiba T. Malondialdehyde as a sensitive marker of inflammation in patients with rheumatoid arthritis. J Assoc Physicians India. 1994 Oct;42(10):775-6.

    PubMed 7876045

Questions about this trial

What is this clinical trial studying?

A study testing Harkány medicinal water in people with Rheumatoid Arthritis and Psoriasis, run by University of Pecs at 1 site 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Katalin Dr Szendi, MD, PhD (+3672536396, szkata82@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dermatology Life Quality Index (DLQI) (time frame: baseline (on admission)). The study lists 16 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 NCT04275206, which also lists 12 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 9 Jun 2020.

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