M79.7
Conditions
Interventions
Group 1: Aldactone(R) 50, Spironolactone (increasing dosages day 1 to 6) up to 200 mg/d p.o. for 28 days
Group 2: Placebo (Dosage of tablets like verum)
Sponsors
Universitätsklinikum Schleswig-Holstein (UKSH)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Fibromyalgia, diagnosed according to ACR 2010 Blood test normal: creatinin, eGFR > 60 ml/min. No known Diabetes mellitus, no known renal disease. BMI > 18 kg/m² No other serious pathological findings in patient history concerning cardio-vascular, renal, pulmonal, haematopoetic, hepatic, endocrin or neuronal functions Written consent after education about course of events and risks of this study Negative pregnancy test Effective (Pearl Index < 1%) contraception measures (inhibitors of ovulation, heterosexual abstinence, menopause, vasectomized partner, bilateral tube occlusion, or combination of two less effective measures)
Exclusion criteria
Exclusion criteria: Known allergic reaction to the study medication (Aldactone® 50 (contains yellow-orange S) or Sinupret eXtract® placebos). Hypotension (RR 10 days) use of NSAID. Other conditions that render the subject inapt for this study according to the investigator. Concomitant participation in other clinical trials (self-reporting).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of FIQ-G-Scores (Fibromyalgia Impact Questionnaire, German version) after 4 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of pain (numeric rating scala, NRS) after 4 weeks Improvement of mood (ADS) after 4 weeks Improvement of quality of life (SF-36) after 4 weeks Raise in Fibromyalgia Impact Questionnaire (FIQ) Scores after 6 weeks Reduction of current analgetic comedication after 4 weeks Assesment of variability of the plasmaconcentration of the active metabolite of spironolactone after 4 weeks, correlation with scores mentioned above | — |
Countries
Germany
Contacts
Public ContactRuwen Böhm
Institut für Experimentelle und Klinische Pharmakologie
Outcome results
None listed