RECRUITINGINTERVENTIONAL
Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
Multicentre, Double-blind, Randomized, Placebo-controlled Trial of Clinical Efficacy of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
About This Trial
Multicentre, double-blind, randomized, placebo-controlled trial of the clinical efficacy of burdock root extract in patients with asymptomatic hyperuricemia, with the primary objective to assess the efficacy of the use of burdock root extract in patients with asymptomatic hyperuricaemia versus placebo
Who May Be Eligible (Plain English)
Who May Qualify:
- Hyperuricaemia confirmed by a laboratory, uric acid level from 360 to 540 μmol/L in women 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 clinical evidences 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 at the end of the trial;
- Not taking any diuretics, or their administration based on a regimen usual for a patient, without changes;
- Not taking part in any other clinical trials;
- Consent and voluntarily signed willing to sign a consent form form for participation in the clinical trial.
Who Should NOT Join This Trial:
- Age \<35 or \>65 years;
- Fever (above 36.8 оС);
- Pregnancy and lactation;
- Patients with any somatic evidences of hyperuricaemia including gout taking antigout drugs 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 with the trial;
- Presence of any concomitant decompensated diseases or acute conditions able to influence 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Hyperuricaemia confirmed by a laboratory, uric acid level from 360 to 540 μmol/L in women 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 clinical evidences 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 at the end of the trial;
* Not taking any diuretics, or their administration based on a regimen usual for a patient, without changes;
* Not taking part in any other clinical trials;
* Consent and voluntarily signed informed consent form for participation in the clinical trial.
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 antigout drugs 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 with the trial;
* Presence of any concomitant decompensated diseases or acute conditions able to influence 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.
Treatments Being Tested
DIETARY_SUPPLEMENT
Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive
Gastric soluble capsules each containing: 750 mg of burdock ( Arctium lappa L.) root extract in the form of a nutritional additive
OTHER
Placebo
Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants
Locations (1)
State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology
Kyiv, Ukraine