Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia (NCT07002762) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
Ukraine100 participantsStarted 2025-03-12
Plain-language 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
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.