Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia

Last updated: July 29, 2025
Sponsor: OMNIFARMA LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gout (Hyperuricemia)

Treatment

Placebo

Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive

Clinical Study ID

NCT07002762
Аrctilappa-100-25
  • Ages 35-65
  • All Genders

Study 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 efficacy of the use of burdock root extract in patients with asymptomatic hyperuricaemia versus placebo

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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
March 12, 2025
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology

    Kyiv, 03151
    Ukraine

    Active - Recruiting

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