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The Anti-inflammatory Effects of Harkány Medicinal Water

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04275206
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Pecs
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Katalin Dr Szendi, MD, PhD
Principal Investigator Affiliation University of Pecs
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Hungary
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis, Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Medicinal water treated group

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.)

Placebo Comparator: Tap water treated group

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.)

Interventions

Other: - Harkány 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.

Other: - Tap water (placebo control)

The control group is treated with tap water.

Contact a Trial Team

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International Sites

Katalin Dr Szendi, Pécs, Baranya, Hungary

Status

Recruiting

Address

Katalin Dr Szendi

Pécs, Baranya, 7624

Site Contact

Katalin Dr Szendi, MD, PhD

szkata82@yahoo.co.uk

+3672536396

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