Nutraceutical on Hyperuricemia

University of Pavia116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

116

Conditions

Hyperuricemia

Interventions

UriceminDRUG

Uricemin is a nutraceutical containing quercetin, rutin, bromelain and L-carnosine

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with uric acid levels between ≥ 6 and \< 7 mg/dl * Patients not taking hypouricemic agents (both pharmaceuticals or nutraceutical agents) Exclusion Criteria: * 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.

Locations (1)

IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

Outcomes

Primary Outcomes

Variation of Hyperuricemia

Uric acid levels

Time frame: 3 months

Data from ClinicalTrials.gov

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