Hyperuricemia or GoutNCT07002762
Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
A study testing Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive in people with Hyperuricemia or Gout, run by OMNIFARMA LLC at 1 site in Ukraine.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Hyperuricemia or Gout
- What is being tested?
- Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUkraine
- Study dates
- 12 Mar 2025to 30 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology
Kyiv, 03151
Valentin Shichkin, 0633639281, shichkin@omnifarma.com.ua
About this study
Official title: Multicentre, Double-blind, Randomized, Placebo-controlled Trial of Clinical Efficacy of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
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
- Conditions
- Hyperuricemia or Gout
- Being tested
- Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive, Placebo
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burdock ( Arctium lappa L.) root extract in a form of a nutritional additiveDietary supplement
Also called LOPUNID, URICA-EURIKA
Gastric soluble capsules each containing: 750 mg of burdock ( Arctium lappa L.) root extract in the form of a nutritional additive
PlaceboOther
Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants
| Study group | Role | What they receive |
|---|---|---|
| Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive. | Active comparator | 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." Receives: Dietary Supplement: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive; Other: Placebo |
| Placebo | Placebo comparator | Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants. The placebo is packed in identical plastic containers marked as "Placebo." Receives: Dietary Supplement: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
Measured: 0 - 60 days
Body weight
kg
Measured: 0 - 60 days
Body mass index
Measured: 0 - 60 days
Purpouse of the trial
- 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.
- To study safety of administration of IMP.
Measured: Till end of 2025 year
Secondary outcomes (1)
Uric acid
μmol/L
Measured: 0 - 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start12 Mar 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperuricemia or GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OMNIFARMA LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002762
- Sponsor's protocol ID
- Аrctilappa-100-25
- Status last verified
- Jul 2025
- First submitted
- 14 Apr 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided