Hyperuricemia Clinical Trial
Official title:
Preliminary Study of Nutritional Intervention, Randomized, Double Blind, and Controlled Parallel Groups to Evaluate the Effect of Consuming a Combination of of Plant Extracts (BSL_EP026) on Serum Uric Acid in Hypeuricemic Subjects.
Verified date | July 2019 |
Source | Biosearch S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the effect of the combination of a combination of plant extracts (BSL_EP026) on blood and urine uricemia levels in individuals with levels at the limit of the values considered normal or moderately high.
Status | Completed |
Enrollment | 34 |
Est. completion date | March 20, 2020 |
Est. primary completion date | March 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Blood uric acid levels greater than 7 mg/dL in men and 6 mg dL in women. - Accept freely to participate in the study and sign the informed consent document. Exclusion Criteria: - Having treatment that can affect uric acid levels. - Use of diuretics. - Follow a low purine diet. - Take a food supplement or drug that interferes with uric acid metabolism and renal system function. - Have an allergy to birch and/or orthosiphon or another component of the test products. - Low compliance expectation. |
Country | Name | City | State |
---|---|---|---|
Spain | Biosearch Life | Granada | Andalucia |
Lead Sponsor | Collaborator |
---|---|
Biosearch S.A. | Clínica Dr. Miguel Quesada |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uric acid | Uric acid in plasma | 2 weeks | |
Secondary | Uric acid in urine | Uric acid in morning spot urine | 2 weeks | |
Secondary | pH of urine | pH in morning spot urine | 2 weeks | |
Secondary | Blood pressure | Systolic and diastolic pressure during the study | 2 weeks | |
Secondary | Fractional clearance of urate (FCU) | Renal clearance of urate/Renal clearance of creatinine | 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05434858 -
Imagery as Biomarker of Gout
|
N/A | |
Completed |
NCT04060173 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
|
Phase 1 | |
Recruiting |
NCT05504083 -
Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients
|
Phase 2 | |
Completed |
NCT04966325 -
Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
|
Early Phase 1 | |
Completed |
NCT01407874 -
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
|
Phase 2 | |
Completed |
NCT00995618 -
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
|
Phase 2 | |
Completed |
NCT00288158 -
Primary Prevention of Hypertension in Obese Adolescents
|
Phase 2 | |
Terminated |
NCT04987294 -
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
|
Phase 2 | |
Completed |
NCT04236219 -
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT06189404 -
Effect of Tigulixostat on the Pharmacokinetics of Theophylline
|
Phase 1 | |
Recruiting |
NCT05586958 -
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
|
Phase 3 | |
Recruiting |
NCT06084585 -
The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia
|
N/A | |
Recruiting |
NCT06056570 -
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04586803 -
Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers
|
Phase 1 | |
Not yet recruiting |
NCT02944214 -
Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients
|
N/A | |
Completed |
NCT02959918 -
Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
|
Phase 2 | |
Completed |
NCT02557126 -
Study of URC102 to Assess the Safety and Efficacy in Gout Patients
|
Phase 2 | |
Active, not recruiting |
NCT01021241 -
Safety and Efficacy Study of Intravenous Uricase-PEG 20
|
Phase 1 | |
Completed |
NCT00756964 -
Lowering Serum Uric Acid to Prevent Acute Kidney Injury
|
Phase 2 | |
Terminated |
NCT00607152 -
Rasburicase (Fasturtec) Registration Trial
|
Phase 3 |