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RecruitingNCT07002762Updated Jul 30, 2025

Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia

An interventional study of Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive and Placebo in Hyperuricemia or Gout, sponsored by OMNIFARMA LLC. Recruiting at 1 site in Ukraine. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by OMNIFARMA LLC · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Hyperuricemia or Gout

Browse trials for

03

In context

Hyperuricemia

240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.

This study's planned enrollment of 100 is above the median of 68 across 193 interventional studies indexed under Hyperuricemia.

Browse Hyperuricemia studies →

Lead sponsor

OMNIFARMA LLC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form for participation in the clinical trial.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    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."

    Dietary Supplement: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive · Other: Placebo

  • Placebo comparator
    Placebo

    Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants. The placebo is packed in identical plastic containers marked as "Placebo."

    Dietary Supplement: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive · Other: Placebo

Interventions

  • Dietary supplementBurdock ( 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

    Also known as: LOPUNID, URICA-EURIKA

  • OtherPlacebo

    Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants

06

What researchers measure

Primary outcomes

  1. Body temperature

    Time frame: 0 - 60 days

  2. Body weight

    kg

    Time frame: 0 - 60 days

  3. Body mass index

    Time frame: 0 - 60 days

  4. Purpouse of the trial

    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.

    Time frame: Till end of 2025 year

Secondary outcomes

  1. Uric acid

    μmol/L

    Time frame: 0 - 60 days

07

Study locations

1 of 1 sites recruiting
  • State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Cardiology
    Kyiv, 03151, Ukraine
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Sep 2025, 6 months after the start.

Of 26 interventional studies with no phase under Hyperuricemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 34. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2025
First posted
Jun 4, 2025
StartActual
Mar 12, 2025
Primary completionEst.
Sep 30, 2025
CompletionEst.
Sep 30, 2025
Last update
Jul 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07002762
Lead sponsor
OMNIFARMA LLC
Responsible party
Sponsor
First posted
Jun 4, 2025
Start date
Mar 12, 2025
Primary completion
Sep 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Jul 30, 2025

Study contacts

Oleg V Kurchenko, MD
Contact
kurchenko@omnifarma.com.ua
+380503319653

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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