Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
NCT ID: NCT07002762
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-03-12
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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."
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
Placebo
Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants
Placebo
Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants. The placebo is packed in identical plastic containers marked as "Placebo."
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
Placebo
Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants
Interventions
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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
Placebo
Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
65 Years
ALL
No
Sponsors
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OMNIFARMA LLC
INDUSTRY
Responsible Party
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Locations
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State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology
Kyiv, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Аrctilappa-100-25
Identifier Type: -
Identifier Source: org_study_id
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