Status:
RECRUITING
Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
Lead Sponsor:
OMNIFARMA LLC
Conditions:
Hyperuricemia or Gout
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07002762
Start Date
March 12 2025
End Date
September 30 2025
Last Update
July 30 2025
Active Locations (1)
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1
State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology
Kyiv, Ukraine, 03151