Evaluation of the Effects of a Supplement Composed by Quercetin, Rutin, Bromelain and L-carnosine in Patients With Hyperuricemia, a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Variation of Hyperuricemia
研究概览
简要总结
The aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and < 7 mg/dl after 3 months of therapy.
详细描述
The aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and < 7 mg/dl after 3 months of therapy.
Patients will be randomized to Uricemin® or placebo for three months. We will evaluate body weight, fasting plasma glucose (FPG), lipid profile, uricemia (UA), high-sensitivity C-reactive protein (Hs-CRP) at baseline and after 3 months since the study start. Treatment tolerability will be assessed evaluating transaminases, and creatinine, and all adverse events will be recorded.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with uric acid levels between ≥ 6 and < 7 mg/dl
- •Patients not taking hypouricemic agents (both pharmaceuticals or nutraceutical agents)
排除标准
- •Patients with previous gout attack
- •Patients with impaired hepatic function
- •Patient with impaired renal function
- •Patients with gastrointestinal disorders
- •Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
- •Patients with weight change of > 3 Kg during the preceding 3 months
- •Patients with history of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
- •Patients taking (within the previous 3 months) hypouricemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, antidepressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
- •Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.
研究组 & 干预措施
Uricemin
干预措施: Uricemin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Variation of Hyperuricemia
时间窗: 3 months
Uric acid levels
次要结局
未报告次要终点
研究者
Giuseppe Derosa
Principal Investigator
University of Pavia