Chronic inflammatory diseases, such as rheumatoid arthritis, lupus erythematosus, scleroderma, polymyalgia rheumatica, ..
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Men and women aged >18 years with a specialist-confirmed inflammatory rheumatic disease - Measurable disease activity (warm, swollen joints and/or elevated inflammatory markers (e.g., serum CRP)) - Intensification of therapeutic measures with conventional medications within the 6-week study period, either not planned from a medical perspective or not desired by the patient - Obtained written informed consent prior to enrollment in the study
Exclusion criteria
Exclusion criteria: - Severe activity of the inflammatory rheumatic disease requiring, or already planned for, intensification of therapy according to guidelines within 6 weeks - Severe comorbidities that are the primary concern (e.g., advanced cancer, severe psychiatric illness with pronounced psychopathological changes (e.g., delusions, hallucinations, severe affective disorders), usually long-lasting or recurrent, which impair social, occupational, and daily functioning and require specialized psychiatric-psychotherapeutic treatment) and which, in the opinion of the study director, preclude participation in the study - History of drug or alcohol abuse >20g/day (equivalent to 0.5 L beer or 0.25 L wine) - Pregnancy and breastfeeding - Inability to understand the study, e.g., due to language barriers - Participation in another clinical trial within the last 6 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What? Is it feasible to take 300 ml of silica-rich Equisetum tea daily for 4 weeks? When? After week 2 and week 4. How? The feasibility of daily intake is assessed using a Likert rating: 1 = not feasible, 2 = feasible. | — |
Secondary
| Measure | Time frame |
|---|---|
| What? - Tolerability - Safety - Disease activity When? Baseline examinations on day 1, after 2 and 4 weeks, and a final examination 2 weeks after completing the tea regimen. How? - Tolerability: measured using a Likert-style scale: 1 = very poorly tolerated, 2 = poorly tolerated, 3 = moderately tolerated, 4 = well tolerated, 5 = very well tolerated - Safety: complete blood count, gamma-glutamyltransferase (GGT), aspartate aminotransferase (GPT), creatine kinase (CK), creatinine, urea, electrolytes (sodium, potassium, calcium) - Disease activity: CRP, disease-specific questionnaires (DAS28, SLEDAI) | — |
Countries
Germany
Contacts
Universitätsklinikum Freiburg Innere Medizin II / Uni-Zentrum Naturheilkunde