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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Double-blind, Randomized, Placebo-controlled Trial of Clinical Efficacy of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
- ClinicalTrials.gov ID
- NCT07002762
- Acronym / sponsor ID
- Аrctilappa-100-25
- Conditions
- Hyperuricemia or Gout
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- OMNIFARMA LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive. | Active comparator | Dietary Supplement: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive, Other: PlaceboGastric 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." |
| Placebo | Placebo comparator | Dietary Supplement: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive, Other: PlaceboGastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants. The placebo is packed in identical plastic containers marked as "Placebo." |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Burdock ( Arctium lappa L.) root extract in a form of a nutritional additiveAlso: LOPUNID, URICA-EURIKAGastric soluble capsules each containing: 750 mg of burdock ( Arctium lappa L.) root extract in the form of a nutritional additive | Dietary supplement | Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive., Placebo |
| PlaceboGastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants | Other | Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive., Placebo |
Primary outcome
Body temperature
Time frame: 0 - 60 days
Body weight
Time frame: 0 - 60 days
kg
Body mass index
Time frame: 0 - 60 days
Purpouse of the trial
Time frame: 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.
1 secondary outcome
Uric acid
Time frame: 0 - 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oleg V Kurchenko, MD (+380503319653, kurchenko@omnifarma.com.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: 0 - 60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.