Burdock root extract for people with high uric acid without gout

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

This trial will test whether burdock root extract can lower uric acid levels in adults aged 35–65 who have asymptomatic hyperuricaemia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 35 Years to 65 Years
• Sex: All
• Sponsor: Omnifarma LLC (Industry-sponsored)
• Locations: 1 site (Kyiv)
• Trial ID: NCT07002762 on ClinicalTrials.gov

What this trial studies

This is a multicentre, double-blind, randomized, placebo-controlled trial comparing burdock (Arctium lappa) root extract as a nutritional additive against placebo in adults with asymptomatic hyperuricaemia. Participants must be 35–65 years old with lab-confirmed serum uric acid 360–540 μmol/L for women and 420–540 μmol/L for men and have no clinical signs of gout. Key exclusions include active gout, recent antigout medication use, pregnancy or lactation, fever, and concurrent use of other nutritional additives or certain diuretics. The trial is sponsored by OMNIFARMA LLC with recruitment listed at the National Research Centre "Academician M. D. Strazhesko Institute of Cardiology" in Kyiv.

Who should consider this trial

Good fit: Ideal candidates are adults aged 35–65 with laboratory-confirmed asymptomatic hyperuricaemia (women 360–540 μmol/L, men 420–540 μmol/L) who have no clinical signs of gout and are not taking other supplements or interfering medications.

Not a fit: People with active gout, recent antigout drug use, uric acid levels outside the specified ranges, pregnant or breastfeeding individuals, or those on contraindicated diuretics are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could offer an accessible, non-prescription option to help lower uric acid and potentially reduce progression to symptomatic gout.

How similar studies have performed: There is limited high-quality randomized trial evidence for burdock root in lowering uric acid, so this approach remains relatively novel and unproven in rigorous trials.

Eligibility criteria

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.

Where this trial is running

Kyiv

• State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology — Kyiv, Ukraine (Recruiting)

Study contacts

• Study coordinator: Oleg V Kurchenko, MD

Conditions Hyperuricemia or Gout