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

OMNIFARMA LLC

Status: Enrolling

Conditions: Hyperuricemia or Gout

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07002762

Аrctilappa-100-25

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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 informed consent form for participation in the clinical trial.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

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

Active Comparator group

Description:

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."

Treatment:

Other: Placebo

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

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

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