Nutraceutical on Hyperuricemia

Phase 4

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: Uricemin; Drug: Placebo

• Registration Number: NCT04161872
• Lead Sponsor: University of Pavia

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-13
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-08
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uricemin	Uricemin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Variation of Hyperuricemia	3 months	Uric acid levels

Trial Locations

Locations (1)

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Lombardia, Italy