The Anti-inflammatory Effects of Harkány Medicinal Water

Rheumatoid Arthritis Clinical Trial

Official title:

The Anti-inflammatory Effects of Harkány Medicinal Water

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275206
• Other study ID #: 131531
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: June 2020
• Source: University of Pecs
• Contact: Katalin Dr Szendi, MD, PhD
• Phone: +3672536396
• Email: szkata82[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 treatments will be repeated, but patients will receive the other type of water.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Psoriasis
• Rheumatoid Arthritis

Intervention

Other:
• Harkány medicinal water
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)
The control group is treated with tap water.

Locations

Country	Name	City	State
Hungary	Katalin Dr Szendi	Pécs	Baranya

Sponsors (3)

Lead Sponsor	Collaborator
University of Pecs	Harkány Spa Hospital, Hungary, National Research, Development and Innovation Office, Hungary

Country where clinical trial is conducted

Hungary, 

References & Publications (12)

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

Gerencsér G, Szendi K, Berényi 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. — View Citation

Hanzel A, Berényi K, Horváth K, Szendi K, Németh B, Varga C. Evidence for the therapeutic effect of the organic content in Szigetvár 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. — View Citation

Hanzel A, Horvát K, Molics B, Berényi K, Németh B, Szendi K, Varga C. Clinical improvement of patients with osteoarthritis using thermal mineral water at Szigetvár 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. — View Citation

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. — View Citation

Németh B, Ajtay Z, Hejjel L, Ferenci T, Ábrám Z, Murányi 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. Review. — View Citation

Németh B, Kustán P, Németh Á, Lenkey Z, Cziráki 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. Review. Hungarian. — View Citation

Péter I, Jagicza A, Ajtay Z, Boncz I, Kiss I, Szendi K, Kustán P, Németh B. Balneotherapy in Psoriasis Rehabilitation. In Vivo. 2017 Nov-Dec;31(6):1163-1168. — View Citation

Péter I, Jagicza A, Ajtay Z, Kiss I, Németh B. [Psoriasis and oxidative stress]. Orv Hetil. 2016 Nov;157(45):1781-1785. Review. Hungarian. — View Citation

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

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.

Varga C, László M, Gerencsér G, Gyöngyi 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (on admission)
Primary	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%)	baseline (on admission)
Primary	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).	baseline (on admission)
Primary	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.	baseline (on admission)
Primary	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.	baseline (on admission)
Primary	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).	baseline (on admission)
Primary	White blood cell count (Routine laboratory parameter)	Aspecific test for monitoring inflammation.	baseline (on admission)
Primary	Haemoglobin (Routine laboratory parameter)	Part of general laboratory test.	baseline (on admission)
Primary	Haematocrit (Routine laboratory parameter)	Part of general laboratory test.	baseline (on admission)
Primary	WE (Routine laboratory parameter)	Aspecific test for monitoring inflammation.	baseline (on admission)
Primary	Creatinine /eGFR/ (Routine laboratory parameter)	General kidney function.	baseline (on admission)
Primary	Uric acid (Routine laboratory parameter)	Aspecific marker of antioxidant system.	baseline (on admission)
Primary	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.	baseline (on admission)
Primary	Asymmetric dimethylarginine (ADMA)	ADMA is considered as a marker and mediator of oxidative stress and an indicator of vascular well-being.	baseline (on admission)
Primary	Total antioxidant capacity (TAC)	TAC is an easily feasible, widely used method, indirect marker of oxidative stress.	baseline (on admission)
Primary	Malondialdehyde (MDA)	MDA is a well-known biomarker of oxidative stress. It is also a sensitive marker of inflammation in patients with RA.	baseline (on admission)
Secondary	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.	3 weeks (before discharge)
Secondary	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%)	3 weeks (before discharge)
Secondary	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).	3 weeks (before discharge)
Secondary	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.	3 weeks (before discharge)
Secondary	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.	3 weeks (before discharge)
Secondary	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).	3 weeks (before discharge)
Secondary	White blood cell count (Routine laboratory parameter)	Aspecific test for monitoring inflammation.	3 weeks (before discharge)
Secondary	WE (Routine laboratory parameter)	Aspecific test for monitoring inflammation.	3 weeks (before discharge)
Secondary	Creatinine /eGFR/ (Routine laboratory parameter)	General kidney function.	3 weeks (before discharge)
Secondary	Uric acid (Routine laboratory parameter)	Aspecific marker of antioxidant system.	3 weeks (before discharge)
Secondary	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.	3 weeks (before discharge)
Secondary	Asymmetric dimethylarginine (ADMA)	ADMA is considered as a marker and mediator of oxidative stress and an indicator of vascular well-being.	3 weeks (before discharge)
Secondary	Total antioxidant capacity (TAC)	TAC is an easily feasible, widely used method, indirect marker of oxidative stress.	3 weeks (before discharge)
Secondary	Malondialdehyde (MDA)	MDA is a well-known biomarker of oxidative stress. It is also a sensitive marker of inflammation in patients with RA.	3 weeks (before discharge)