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

ConditionHyperuricemia or Gout
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorOMNIFARMA LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive

    Dietary supplement

    Gastric soluble capsules each containing: 750 mg of burdock ( Arctium lappa L.) root extract in the form of a nutritional additive

  • Placebo

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Burdock ( Arctium lappa L.) root extract in a form of a nutritional additive.Active comparator 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OMNIFARMA LLC

Lead sponsor

Source ClinicalTrials.gov
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