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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2012110611384N1 |
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Date of registration:
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2012-12-03 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dopamine receptor in hypertension with Polycystic Kidney Disease
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Scientific title:
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Study the role of dopamine receptors on the structure and function of endothelial primary cilia in vitro and in vivo |
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Date of first enrolment:
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2012-06-01 |
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Target sample size:
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30 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/11646 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment.
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Phase:
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2-3
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Countries of recruitment
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Iraq
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Contacts
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Name:
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Surya M. Nauli
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Address:
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3000 Arlington ave
43614
Toledo
United States |
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Telephone:
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001419383-1921 |
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Email:
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surya.nauli@utoledo.edu |
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Affiliation:
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College of Pharmacy and Medicine, University of Toledo |
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Name:
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Sarmed H. Kathem
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Address:
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Babalmoadhum 14026
Baghdad
Iraq |
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Telephone:
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009647901552609 |
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Email:
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sarmed.kathem11@utoledo.edu |
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Affiliation:
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College of Pharmacy-University of Baghdad; College of Pharmacy-University of Toledo |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: adult type polycystic kidney disease with borderline hypertension; Control group inclusion criteria are essential borderline hypertension without any secondary cause.
Exclusion criteria are: Pregnancy, lactation, diabetes mellitus, myocardial infarction, angina, arrhythmias, renal transplantation, renal failure, serum creatinin more than 3mg/dL, dialysis, sever hypertension, recieving antihypertensive drugs.
Exclusion criteria:
Age minimum:
25 years
Age maximum:
45 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Polycystic kidney, autosomal dominant Polycystic kidney, adult type
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Adult Polycystic Kidney Disease.
Polycystic kidney, autosomal dominant Polycystic kidney, adult type
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Intervention(s)
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control, placebo capsule three times daily for 7 days; domperidone 20 mg also used in this group to simulate drug group
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Intervention 1: Levodopa 50 mg capsule three times daily for 7 days; Domperidone 20 mg to reduce nausea used 30 minutes before Levodopa dose for 7 days. Intervention 2: Levodopa 100 mg capsule, three times daily for 7 days; Domperidone 20 mg to reduce nausea used 30 minutes before levodopa dose for 7 days. Intervention 3: control, placebo capsule three times daily for 7 days; domperidone 20 mg also used in this group to simulate drug group.
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Levodopa 50 mg capsule three times daily for 7 days; Domperidone 20 mg to reduce nausea used 30 minutes before Levodopa dose for 7 days
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Levodopa 100 mg capsule, three times daily for 7 days; Domperidone 20 mg to reduce nausea used 30 minutes before levodopa dose for 7 days
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Treatment - Drugs
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Placebo
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Primary Outcome(s)
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Serum Nitric Oxide. Timepoint: 0 hour, 7 days. Method of measurement: serum detection by Greiss reaction (colorimetric).
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Blood Pressure. Timepoint: 0 hour, 2 hours, 7 days. Method of measurement: mercury sphygmomanometer.
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Secondary Outcome(s)
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Aspartate Aminotransferase. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Heart rate. Timepoint: 0 hour, 2 hour, 7 days. Method of measurement: radial pulse method.
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Alanine Aminotransferase. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Assymetric dimethylarginine. Timepoint: 0 hour, 7 days. Method of measurement: serum samples by ELISA.
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Serum Creatinin. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Urea. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Alkaline Phosphatase. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Body Mass Index. Timepoint: baseline. Method of measurement: Weight (kg)/Height (sequare meter).
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Albumin. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Calcium. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Potassium. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Sodium. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Total Bilirubin. Timepoint: 0 hour, 7 days. Method of measurement: serum sample by ready made kit.
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Source(s) of Monetary Support
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The Dean, College of Pharmacy, University of Baghdad
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of College of Pharmacy- graduate study committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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