The Anti-inflammatory Effects of Harkány Medicinal Water

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04275206
• Date of registration: 14/02/2020
• Prospective Registration: Yes
• Primary sponsor: University of Pecs
• Public title: The Anti-inflammatory Effects of Harkány Medicinal Water
• Scientific title: The Anti-inflammatory Effects of Harkány Medicinal Water
• Date of first enrolment: June 1, 2020
• Target sample size: 350
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04275206
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Hungary

Contacts

• Name: Katalin Dr Szendi, MD, PhD

• Name: Katalin Dr Szendi, MD, PhD
• Affiliation: University of Pecs

• Name: Katalin Dr Szendi, MD, PhD

Key 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Rheumatoid Arthritis

Intervention(s)

Other: Harkány medicinal water

Other: Tap water (placebo control)

Primary Outcome(s)

Dermatology Life Quality Index (DLQI) [Time Frame: baseline (on admission)]

Haemoglobin (Routine laboratory parameter) [Time Frame: baseline (on admission)]

Creatinine /eGFR/ (Routine laboratory parameter) [Time Frame: baseline (on admission)]

High sensitivity C-reactive protein (hs-CRP) [Time Frame: baseline (on admission)]

Malondialdehyde (MDA) [Time Frame: baseline (on admission)]

Asymmetric dimethylarginine (ADMA) [Time Frame: baseline (on admission)]

SF-36 [Time Frame: baseline (on admission)]

Haematocrit (Routine laboratory parameter) [Time Frame: baseline (on admission)]

Total antioxidant capacity (TAC) [Time Frame: baseline (on admission)]

WE (Routine laboratory parameter) [Time Frame: baseline (on admission)]

White blood cell count (Routine laboratory parameter) [Time Frame: baseline (on admission)]

Disease Activity Score Calculator for Rheumatoid Arthritis (DAS 28) [Time Frame: baseline (on admission)]

Psoriasis Area Severity Index (PASI) [Time Frame: baseline (on admission)]

Patient Uncertainty Questionnaire-Rheumatology (PUQ-R) [Time Frame: baseline (on admission)]

Functional Independence Measure (FIM) [Time Frame: baseline (on admission)]

Uric acid (Routine laboratory parameter) [Time Frame: baseline (on admission)]

Secondary Outcome(s)

Dermatology Life Quality Index (DLQI) [Time Frame: 3 weeks (before discharge)]

Functional Independence Measure (FIM) [Time Frame: 3 weeks (before discharge)]

Disease Activity Score Calculator for Rheumatoid Arthritis (DAS 28) [Time Frame: 3 weeks (before discharge)]

High sensitivity C-reactive protein (hs-CRP) [Time Frame: 3 weeks (before discharge)]

Psoriasis Area Severity Index (PASI) [Time Frame: 3 weeks (before discharge)]

Creatinine /eGFR/ (Routine laboratory parameter) [Time Frame: 3 weeks (before discharge)]

Total antioxidant capacity (TAC) [Time Frame: 3 weeks (before discharge)]

WE (Routine laboratory parameter) [Time Frame: 3 weeks (before discharge)]

Patient Uncertainty Questionnaire-Rheumatology (PUQ-R) [Time Frame: 3 weeks (before discharge)]

White blood cell count (Routine laboratory parameter) [Time Frame: 3 weeks (before discharge)]

Malondialdehyde (MDA) [Time Frame: 3 weeks (before discharge)]

Uric acid (Routine laboratory parameter) [Time Frame: 3 weeks (before discharge)]

Asymmetric dimethylarginine (ADMA) [Time Frame: 3 weeks (before discharge)]

SF-36 [Time Frame: 3 weeks (before discharge)]

Secondary ID(s)

131531

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Harkány Spa Hospital, Hungary

National Research, Development and Innovation Office, Hungary