Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Psoriasis
  • Rheumatoid Arthritis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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.Masking: Quadruple (Participant, Care Provider, 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.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04275206
Collaborators
  • National Research, Development and Innovation Office, Hungary
  • Harkány Spa Hospital, Hungary
Investigators
Principal Investigator: Katalin Dr Szendi, MD, PhD University of Pecs