The Anti-inflammatory Effects of Harkány Medicinal Water

University of Pecs

Status: Unknown

Conditions: Psoriasis; Rheumatoid Arthritis

Treatments: Other: Tap water (placebo control); Other: Harkány medicinal water

Study type: Interventional

Funder types: Other

Identifiers

NCT04275206

131531

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups, including a placebo group

Medicinal water treated group

Experimental group

Description:

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.)

Treatment:

Other: Harkány medicinal water

Tap water treated group

Placebo Comparator group

Description:

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.)

Treatment:

Other: Tap water (placebo control)