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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ukraine
State Institution National Research Centre Academician M. D. Strazhesko Institute of Cardiology
RECRUITING
Kyiv
Contact Information
Primary
Oleg V Kurchenko, MD
kurchenko@omnifarma.com.ua
+380503319653
Time Frame
Start Date: 2025-03-12
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 100
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: OMNIFARMA LLC

This content was sourced from clinicaltrials.gov