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

Официальное название

Multicentre, Double-blind, Randomized, Placebo-controlled Trial of Clinical Efficacy of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia

Обзор

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

Вмешательства

• Пищевая добавка 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
• Другое Placebo
  Gastric soluble capsules each containing: Maltodextrin, silicon dioxide, calcium stearate, food colourants

Первичные конечные точки

• Body temperature [Срок оценки: 0 - 60 days]
• Body weight [Срок оценки: 0 - 60 days]
• Body mass index [Срок оценки: 0 - 60 days]
• Purpouse of the trial [Срок оценки: Till end of 2025 year]

Вторичные конечные точки (1)

• Uric acid [Срок оценки: 0 - 60 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Украина · 1 центр

• State Institution "National Research Centre "Academician M. D. Strazhesko Institute of Car — Kyiv

Идентификаторы

NCT: NCT07002762 · Аrctilappa-100-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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