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

Not Applicable

Recruiting

• Conditions: Hyperuricemia or Gout

• Registration Number: NCT07002762
• Lead Sponsor: OMNIFARMA LLC

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-12
• Study First Submitted: 2025-04-14
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body temperature	0 - 60 days
Body weight	0 - 60 days	kg
Body mass index	0 - 60 days
Purpouse of the trial	Till end of 2025 year	1. 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.; 2. To study safety of administration of IMP.

Secondary Outcome Measures

Name	Time	Method
Uric acid	0 - 60 days	μmol/L

Trial Locations

Locations (1)

State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology; 🇺🇦 Kyiv, Ukraine