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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: |
IRCT138904144312N1 |
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Date of registration:
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2014-08-16 |
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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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Effect of Atrovastatin on lung inflammation in bronchitis
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Scientific title:
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Evaluation of the effect of Atrovastatin on inflammatory markers in sulfur mutsard gas induced chronic bronchitis |
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Date of first enrolment:
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2014-06-29 |
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Target sample size:
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90 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/4577 |
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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: Parallel, Purpose: Treatment.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr seyed Masoom Masoompour
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Address:
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Internal Medicine Department, Nemazee Hospital, Nemazee Squ
Shiraz
Iran (Islamic Republic of) |
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Telephone:
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+98 71 1647 4316 |
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Email:
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masoomm@sums.ac.ir |
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Affiliation:
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Shiraz University of Medical Sciences |
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Name:
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seyed Masoom Masoompour
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Address:
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Internal Medicine Department, Nemazee Hospital, Nemazee Squ
shiraz
Iran (Islamic Republic of) |
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Telephone:
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+98 71 1647 4316 |
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Email:
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masoomm@sums.ac.ir |
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Affiliation:
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Shiraz University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: exposure to mustard gas during the Iran-Iraq war and have suffered from chronic bronchitis (history of chronic cough and sputum daily for 3 months during recent 2 years)
Exclusion criteria: Using statin in the last 3 months of study starting time; exacerbation of symptoms in the past 4 weeks; connective tissue disease; sarcoidosis; eosinophilic granuloma; pneumoconiosis; lymphoma; carcinomatous; smokers
Exclusion criteria:
Age minimum:
45 years
Age maximum:
75 years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Chronic bronchitis.
Chronic bronchitis: obstructive
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Chronic bronchitis: obstructive
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Intervention(s)
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Intervention 1: Intervention group:40 mg atorvastatin daily for 3 months. Intervention 2: Control group: one placebo tablet daily for 3 months.
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Control group: one placebo tablet daily for 3 months
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Intervention group:40 mg atorvastatin daily for 3 months
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Treatment - Drugs
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Primary Outcome(s)
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Added at 2015-08-05: Procalcitonin. Timepoint: Added at 2015-08-05: At the beginning of the intervention and 3 months after intervention. Method of measurement: Added at 2015-08-05: ELISA.
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Interleukin 6 level. Timepoint: before intervention - 3 month after intervention. Method of measurement: ELISA test is performed.
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TNF alpha level. Timepoint: before intervention - 3 month after intervention. Method of measurement: ELISA test is performed.
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Secondary Outcome(s)
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Withe blood cell count. Timepoint: before intervention - 3 month after intervention. Method of measurement: Complete Blood Count.
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Added at 2015-08-05: hs-CRP. Timepoint: Added at 2015-08-05: At the beginning the intervention and 3 months after intervention. Method of measurement: Added at 2015-08-05: Immunoassay.
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Source(s) of Monetary Support
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shiraz University Of medical Science
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Shiraz University of Medical Sciences
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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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