Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
116 participants
INTERVENTIONAL
2018-10-01
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Uricemin
Uricemin
Uricemin is a nutraceutical containing quercetin, rutin, bromelain and L-carnosine
Placebo
Placebo
Placebo
Interventions
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Uricemin
Uricemin is a nutraceutical containing quercetin, rutin, bromelain and L-carnosine
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients not taking hypouricemic agents (both pharmaceuticals or nutraceutical agents)
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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University of Pavia
OTHER
Responsible Party
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Giuseppe Derosa
Principal Investigator
Locations
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IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Countries
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Other Identifiers
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P-20180016368
Identifier Type: -
Identifier Source: org_study_id