Nutraceutical on Hyperuricemia

University of Pavia

Status and phase

Completed

Phase 4

Conditions

Hyperuricemia

Treatments

Drug: Uricemin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04161872

P-20180016368

Details and patient eligibility

About

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.

Full description

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.

Enrollment

116 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.