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

Multicentre, Double-blind, Randomized, Placebo-controlled Trial of Clinical Efficacy 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

Study Overview

• Status: Recruiting
• Conditions: Hyperuricemia or Gout
• Intervention / Treatment: Dietary supplement: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oleg V Kurchenko, MD; Phone Number: +380503319653; Email: kurchenko@omnifarma.com.ua

Study Locations

• Ukraine
  • Kyiv, Ukraine, 03151
    • Recruiting
    • State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology
    • Contact: Valentin Shichkin; Phone Number: 0633639281; Email: shichkin@omnifarma.com.ua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive.; Gastric soluble capsules each containing: 750 mg of burdock ( Arctium lappa L.) root extract in the form of a nutritional additive. The investigational product is packed in identical plastic containers marked as "Investigational Medicinal Product."	Dietary supplement: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive; 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; Other: Placebo; Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants
Placebo Comparator: Placebo; Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants. The placebo is packed in identical plastic containers marked as "Placebo."	Dietary supplement: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive; 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; Other: Placebo; Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature		0 - 60 days
Body weight	kg	0 - 60 days
Body mass index		0 - 60 days
Purpouse of the trial	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.	Till end of 2025 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uric acid	μmol/L	0 - 60 days

Collaborators and Investigators

• Sponsor: OMNIFARMA LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: May 25, 2025
• First Posted (Actual): June 4, 2025

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: Аrctilappa-100-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No