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

NCT07002762 | Recruiting

• 1 other identifier: Аrctilappa-100-25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperuricemia or Gout

Outcome Measures

Primary Outcomes (4)

• Body temperature

  0 - 60 days

• Body weight

  kg

  0 - 60 days

• Body mass index

  0 - 60 days

• Purpouse of the trial

  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.

  Till end of 2025 year

Secondary Outcomes (1)

• Uric acid

  0 - 60 days

Study Arms (2)

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

ACTIVE COMPARATOR

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; Other: Placebo

Placebo

PLACEBO COMPARATOR

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; Other: Placebo

Interventions

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

Also known as: LOPUNID, URICA-EURIKA

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

Placebo OTHER

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

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

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OMNIFARMA LLC: lead

Study Sites (1)

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

Kyiv, 03151, Ukraine

RECRUITING

MeSH Terms

Conditions

Hyperuricemia; Gout

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Oleg V Kurchenko, MD

CONTACT

+380503319653; kurchenko@omnifarma.com.ua

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: June 4, 2025
• Study Start: March 12, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

UA (1)