Hyperuricemia or Gout
Conditions
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
Interventions
DIETARY_SUPPLEMENTBurdock ( 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
OTHERPlacebo
Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants
Sponsors
OMNIFARMA LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Uric acid | 0 - 60 days | μmol/L |
Countries
Ukraine
Contacts
Primary ContactOleg V Kurchenko, MD
Outcome results
None listed