Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive, Placebo.
- Who it may be relevant to
- Registry conditions: Hyperuricemia or Gout. Basic parameters: 35 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicentre, Double-blind, Randomized, Placebo-controlled Trial of Clinical Efficacy of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
Overview
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 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 Placebo
Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants
Primary outcome measures
- Body temperature [Time frame: 0 - 60 days]
- Body weight [Time frame: 0 - 60 days]
- Body mass index [Time frame: 0 - 60 days]
- Purpouse of the trial [Time frame: Till end of 2025 year]
Secondary outcome measures (1)
- Uric acid [Time frame: 0 - 60 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Ukraine · 1 center
- State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Car — Kyiv
Identifiers
NCT: NCT07002762 · Аrctilappa-100-25