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NCT Number: NCT07002762

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

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

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kyiv, 03151, Ukraine

Location status: Recruiting

Location contact

Valentin Shichkin

CONTACT

[email protected]

0633639281

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

Gastric soluble capsules each containing: 750 mg of burdock ( Arctium lappa L.) root extract in the form of a nutritional additive

Other names: LOPUNID, URICA-EURIKA

Placebo

Other

Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants

Primary outcomes

  1. Body temperature

    Time frame: 0 - 60 days

  2. Body weight

    Time frame: 0 - 60 days

    kg

  3. Body mass index

    Time frame: 0 - 60 days

  4. Purpouse of the trial

    Time frame: Till end of 2025 year

    • To study blood levels of uric acid before and after the two-months administration of IMP and placebo in a dose of 1 capsule twice per day in patients with asymptomatic hyperuricaemia and a baseline level of uric acid from 360 to 540 μmol/L in women and from 420 to 540 μmol/L in men.
    • To study safety of administration of IMP.

Secondary outcomes

  1. Uric acid

    Time frame: 0 - 60 days

    μmol/L

Study contacts

Contact information is provided by the study sponsor or research team.

Oleg V Kurchenko, MD

CONTACT

[email protected]

+380503319653

Sponsors and collaborators

Lead sponsor

OMNIFARMA LLC

Industry

Registry information

Official study title

Multicentre, Double-blind, Randomized, Placebo-controlled Trial of Clinical Efficacy of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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