Multicentre, Double-blind, Randomized, Placebo-controlled Trial of Clinical Efficacy of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Body temperature
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Body temperature
时间窗: 0 - 60 days
Body weight
时间窗: 0 - 60 days
kg
Body mass index
时间窗: 0 - 60 days
Purpouse of the trial
时间窗: 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.
次要结局
- Uric acid(0 - 60 days)