Psoriasis, Rheumatoid Arthritis
Conditions
Keywords
medicinal water,inflammation,biomarker,inflammatory disease
Brief 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.
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.
Interventions
OTHERHarkány 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.
OTHERTap water (placebo control)
The control group is treated with tap water.
Sponsors
National Research, Development and Innovation Office, Hungary
Harkány Spa Hospital, Hungary
University of Pecs
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants: Tap water and medicinal water have the same pH, colour, smell; in another study we proved that they could not differentiate them. Care providers do not know if tap water or medicinal water was installed in the bath tub. Investigator: Control and treated patients are encoded. Outcome assessor can see only the encoded measurement results.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malondialdehyde (MDA) | baseline (on admission) | MDA is a well-known biomarker of oxidative stress. It is also a sensitive marker of inflammation in patients with RA. |
| Functional Independence Measure (FIM) | baseline (on admission) | 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%) |
| SF-36 | baseline (on admission) | 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). |
| Patient Uncertainty Questionnaire-Rheumatology (PUQ-R) | baseline (on admission) | 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. |
| Psoriasis Area Severity Index (PASI) | baseline (on admission) | 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. |
| Disease Activity Score Calculator for Rheumatoid Arthritis (DAS 28) | baseline (on admission) | 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). |
| White blood cell count (Routine laboratory parameter) | baseline (on admission) | Aspecific test for monitoring inflammation. |
| Haemoglobin (Routine laboratory parameter) | baseline (on admission) | Part of general laboratory test. |
| Haematocrit (Routine laboratory parameter) | baseline (on admission) | Part of general laboratory test. |
| WE (Routine laboratory parameter) | baseline (on admission) | Aspecific test for monitoring inflammation. |
| Creatinine /eGFR/ (Routine laboratory parameter) | baseline (on admission) | General kidney function. |
| Uric acid (Routine laboratory parameter) | baseline (on admission) | Aspecific marker of antioxidant system. |
| High sensitivity C-reactive protein (hs-CRP) | baseline (on admission) | hs-CRP is an aspecific inflammatory parameter, involved in most risk evaluation systems and generally used in clinical practice. |
| Asymmetric dimethylarginine (ADMA) | baseline (on admission) | ADMA is considered as a marker and mediator of oxidative stress and an indicator of vascular well-being. |
| Total antioxidant capacity (TAC) | baseline (on admission) | TAC is an easily feasible, widely used method, indirect marker of oxidative stress. |
| Dermatology Life Quality Index (DLQI) | baseline (on admission) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure (FIM) | 3 weeks (before discharge) | 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%) |
| SF-36 | 3 weeks (before discharge) | 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). |
| Patient Uncertainty Questionnaire-Rheumatology (PUQ-R) | 3 weeks (before discharge) | 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. |
| Psoriasis Area Severity Index (PASI) | 3 weeks (before discharge) | 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. |
| Disease Activity Score Calculator for Rheumatoid Arthritis (DAS 28) | 3 weeks (before discharge) | 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). |
| White blood cell count (Routine laboratory parameter) | 3 weeks (before discharge) | Aspecific test for monitoring inflammation. |
| WE (Routine laboratory parameter) | 3 weeks (before discharge) | Aspecific test for monitoring inflammation. |
| Creatinine /eGFR/ (Routine laboratory parameter) | 3 weeks (before discharge) | General kidney function. |
| Uric acid (Routine laboratory parameter) | 3 weeks (before discharge) | Aspecific marker of antioxidant system. |
| High sensitivity C-reactive protein (hs-CRP) | 3 weeks (before discharge) | hs-CRP is an aspecific inflammatory parameter, involved in most risk evaluation systems and generally used in clinical practice. |
| Asymmetric dimethylarginine (ADMA) | 3 weeks (before discharge) | ADMA is considered as a marker and mediator of oxidative stress and an indicator of vascular well-being. |
| Total antioxidant capacity (TAC) | 3 weeks (before discharge) | TAC is an easily feasible, widely used method, indirect marker of oxidative stress. |
| Malondialdehyde (MDA) | 3 weeks (before discharge) | MDA is a well-known biomarker of oxidative stress. It is also a sensitive marker of inflammation in patients with RA. |
| Dermatology Life Quality Index (DLQI) | 3 weeks (before discharge) | 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. |
Countries
Hungary
Contacts
Primary ContactKatalin Dr Szendi, MD, PhD
Backup ContactBalázs Dr Németh, MD, PhD
Outcome results
None listed