NCT04161872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

November 10, 2019

Last Update Submit

November 8, 2020

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Variation of Hyperuricemia

    Uric acid levels

    3 months

Study Arms (2)

Uricemin

ACTIVE COMPARATOR
Drug: Uricemin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

UriceminDRUG

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

Uricemin
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with uric acid levels between ≥ 6 and \< 7 mg/dl
  • Patients not taking hypouricemic agents (both pharmaceuticals or nutraceutical agents)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 13, 2019

Study Start

October 1, 2018

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

IT(1)