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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Gastric soluble capsules each containing: 750 mg of burdock ( Arctium lappa L.) root extract in the form of a nutritional additive
Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants
State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology
Kyiv, Ukraine
RECRUITINGBody temperature
Time frame: 0 - 60 days
Body weight
kg
Time frame: 0 - 60 days
Body mass index
Time frame: 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.
Time frame: Till end of 2025 year
Uric acid
μmol/L
Time frame: 0 - 60 days
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