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OpenTrials
Completed

NCT Number: NCT04161872

Nutraceutical on Hyperuricemia

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Uricemin

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. Variation of Hyperuricemia

    Time frame: 3 months

    Uric acid levels

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2019
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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