An interventional study of Harkány medicinal water and Tap water (placebo control) in Rheumatoid Arthritis and Psoriasis, sponsored by University of Pecs. Status unknown at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by University of Pecs · Not applicable, Interventional, and Treatment
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.
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.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's planned enrollment of 350 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →University of Pecs is the lead sponsor of 105 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
3-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.)
Other: Harkány medicinal water
3-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.)
Other: Tap water (placebo control)
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.
The control group is treated with tap water.
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.
Time frame: baseline (on admission)
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%)
Time frame: baseline (on admission)
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).
Time frame: baseline (on admission)
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.
Time frame: baseline (on admission)
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.
Time frame: baseline (on admission)
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).
Time frame: baseline (on admission)
White blood cell count (Routine laboratory parameter)
Aspecific test for monitoring inflammation.
Time frame: baseline (on admission)
Haemoglobin (Routine laboratory parameter)
Part of general laboratory test.
Time frame: baseline (on admission)
Haematocrit (Routine laboratory parameter)
Part of general laboratory test.
Time frame: baseline (on admission)
WE (Routine laboratory parameter)
Aspecific test for monitoring inflammation.
Time frame: baseline (on admission)
Creatinine /eGFR/ (Routine laboratory parameter)
General kidney function.
Time frame: baseline (on admission)
Uric acid (Routine laboratory parameter)
Aspecific marker of antioxidant system.
Time frame: baseline (on admission)
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.
Time frame: baseline (on admission)
Asymmetric dimethylarginine (ADMA)
ADMA is considered as a marker and mediator of oxidative stress and an indicator of vascular well-being.
Time frame: baseline (on admission)
Total antioxidant capacity (TAC)
TAC is an easily feasible, widely used method, indirect marker of oxidative stress.
Time frame: baseline (on admission)
Malondialdehyde (MDA)
MDA is a well-known biomarker of oxidative stress. It is also a sensitive marker of inflammation in patients with RA.
Time frame: baseline (on admission)
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.
Time frame: 3 weeks (before discharge)
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%)
Time frame: 3 weeks (before discharge)
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).
Time frame: 3 weeks (before discharge)
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.
Time frame: 3 weeks (before discharge)
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.
Time frame: 3 weeks (before discharge)
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).
Time frame: 3 weeks (before discharge)
White blood cell count (Routine laboratory parameter)
Aspecific test for monitoring inflammation.
Time frame: 3 weeks (before discharge)
WE (Routine laboratory parameter)
Aspecific test for monitoring inflammation.
Time frame: 3 weeks (before discharge)
Creatinine /eGFR/ (Routine laboratory parameter)
General kidney function.
Time frame: 3 weeks (before discharge)
Uric acid (Routine laboratory parameter)
Aspecific marker of antioxidant system.
Time frame: 3 weeks (before discharge)
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.
Time frame: 3 weeks (before discharge)
Asymmetric dimethylarginine (ADMA)
ADMA is considered as a marker and mediator of oxidative stress and an indicator of vascular well-being.
Time frame: 3 weeks (before discharge)
Total antioxidant capacity (TAC)
TAC is an easily feasible, widely used method, indirect marker of oxidative stress.
Time frame: 3 weeks (before discharge)
Malondialdehyde (MDA)
MDA is a well-known biomarker of oxidative stress. It is also a sensitive marker of inflammation in patients with RA.
Time frame: 3 weeks (before discharge)
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available within 6 month of study completion.
Access criteria: Requests will be reviewed and requestors will be required to sign a Data Access Agreement.
Start is estimated for Jun 2020; primary completion for Nov 2020, 5 months later.
Of 262 non-industry interventional studies with no phase under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 5 months is below that.
Counting every sponsor, half of 301 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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