Nutraceutical on Hyperuricemia

Hyperuricemia Clinical Trial

Official title:

Evaluation of the Effects of a Supplement Composed by Quercetin, Rutin, Bromelain and L-carnosine in Patients With Hyperuricemia, a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161872
• Other study ID #: P-20180016368
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2020
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• Uricemin
Uricemin is a nutraceutical containing quercetin, rutin, bromelain and L-carnosine
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Matteo	Pavia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of Hyperuricemia	Uric acid levels	3 months