The Anti-inflammatory Effects of Harkány Medicinal Water
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Haemoglobin (Routine laboratory parameter)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Haemoglobin (Routine laboratory parameter)
时间窗: baseline (on admission)
Part of general laboratory test.
Dermatology Life Quality Index (DLQI)
时间窗: 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.
Psoriasis Area Severity Index (PASI)
时间窗: 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.
Functional Independence Measure (FIM)
时间窗: 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
时间窗: 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)
时间窗: 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.
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS 28)
时间窗: 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)
时间窗: baseline (on admission)
Aspecific test for monitoring inflammation.
Haematocrit (Routine laboratory parameter)
时间窗: baseline (on admission)
Part of general laboratory test.
High sensitivity C-reactive protein (hs-CRP)
时间窗: baseline (on admission)
hs-CRP is an aspecific inflammatory parameter, involved in most risk evaluation systems and generally used in clinical practice.
WE (Routine laboratory parameter)
时间窗: baseline (on admission)
Aspecific test for monitoring inflammation.
Creatinine /eGFR/ (Routine laboratory parameter)
时间窗: baseline (on admission)
General kidney function.
Asymmetric dimethylarginine (ADMA)
时间窗: baseline (on admission)
ADMA is considered as a marker and mediator of oxidative stress and an indicator of vascular well-being.
Uric acid (Routine laboratory parameter)
时间窗: baseline (on admission)
Aspecific marker of antioxidant system.
Total antioxidant capacity (TAC)
时间窗: baseline (on admission)
TAC is an easily feasible, widely used method, indirect marker of oxidative stress.
Malondialdehyde (MDA)
时间窗: baseline (on admission)
MDA is a well-known biomarker of oxidative stress. It is also a sensitive marker of inflammation in patients with RA.
次要结局
- Patient Uncertainty Questionnaire-Rheumatology (PUQ-R)(3 weeks (before discharge))
- Psoriasis Area Severity Index (PASI)(3 weeks (before discharge))
- WE (Routine laboratory parameter)(3 weeks (before discharge))
- Dermatology Life Quality Index (DLQI)(3 weeks (before discharge))
- Functional Independence Measure (FIM)(3 weeks (before discharge))
- SF-36(3 weeks (before discharge))
- High sensitivity C-reactive protein (hs-CRP)(3 weeks (before discharge))
- Disease Activity Score Calculator for Rheumatoid Arthritis (DAS 28)(3 weeks (before discharge))
- White blood cell count (Routine laboratory parameter)(3 weeks (before discharge))
- Asymmetric dimethylarginine (ADMA)(3 weeks (before discharge))
- Total antioxidant capacity (TAC)(3 weeks (before discharge))
- Malondialdehyde (MDA)(3 weeks (before discharge))
- Creatinine /eGFR/ (Routine laboratory parameter)(3 weeks (before discharge))
- Uric acid (Routine laboratory parameter)(3 weeks (before discharge))