Phase
Condition
Gout (Hyperuricemia)
Treatment
Placebo
Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive
Clinical Study ID
Ages 35-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Hyperuricaemia confirmed by a laboratory, uric acid level from 360 to 540 μmol/L inwomen and from 420 to 540 μmol/L in men;
Age from 35 to 65 years at the baseline;
Patients examined by an experienced specialist not revealing any clinicalevidences of gout or other somatic consequences of hyperuricaemia;
Not taking any other nutritional additives;
Women of reproductive age having negative pregnancy test at the baseline and atthe end of the trial;
Not taking any diuretics, or their administration based on a regimen usual fora patient, without changes;
Not taking part in any other clinical trials;
Consent and voluntarily signed informed consent form for participation in theclinical trial.
Exclusion
Exclusion Criteria:
Age <35 or >65 years;
Fever (above 36.8 оС);
Pregnancy and lactation;
Patients with any somatic evidences of hyperuricaemia including gout taking antigoutdrugs during or within 6 months before the trial;
Patients with mental disorders / taking antipsychotics or antidepressants;
Patients not giving (informed) consent to participate in the trial;
Patients causing doubts of the study doctor as to their motivation to comply withthe trial;
Presence of any concomitant decompensated diseases or acute conditions able toinfluence results of the trial;
Alcohol abuse and drug addiction;
Changes in taking diuretics within a month before and during the trial;
Participation in any other clinical trial;
Taking any nutritional additives.
Study Design
Connect with a study center
State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology
Kyiv, 03151
UkraineActive - Recruiting
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