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Nutraceutical on Hyperuricemia

Primary Purpose

Hyperuricemia

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Uricemin
Placebo
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • IRCCS Policlinico San Matteo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Uricemin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Variation of Hyperuricemia
Uric acid levels

Secondary Outcome Measures

Full Information

First Posted
November 10, 2019
Last Updated
November 8, 2020
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04161872
Brief Title
Nutraceutical on Hyperuricemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Uricemin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Uricemin
Intervention Description
Uricemin is a nutraceutical containing quercetin, rutin, bromelain and L-carnosine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Variation of Hyperuricemia
Description
Uric acid levels
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

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Nutraceutical on Hyperuricemia

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