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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: |
IRCT2014101811763N17 |
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Date of registration:
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2016-02-04 |
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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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The comparative effect of Plantago Psyllium, Ocimum Basilicum seeds on non alcoholic fatty liver disease
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Scientific title:
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Comparative study on the effect of Plantago Psyllium and Ocimum Basilicum seeds on body composition, blood sugar, lipid profile, liver enzymes, inflammatory index and sonografic finding in nonalcoholic fatty liver patients |
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Date of first enrolment:
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2014-08-11 |
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Target sample size:
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120 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/11927 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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N/A
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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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Gholam Reza Askari
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Address:
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Nutrition Department, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan
Iran (Islamic Republic of) |
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Telephone:
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+98 31 3792 6000 |
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Email:
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askari@mui.ac.ir |
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Affiliation:
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Isfahan University of Medical Sciences |
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Name:
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Gholam Reza Askari
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Address:
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Nutrition Department, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan
Iran (Islamic Republic of) |
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Telephone:
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+98 31 3792 6000 |
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Email:
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askari@mui.ac.ir |
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Affiliation:
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Isfahan University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: inclusion criteria: Males and females above 20 years nonalcoholic fatty liver that was confirmed at the first time by one specialist.
exclusion criteria: Hemocromatosis; insulin injection; persistent use of Corticosteroids; alcohol abuse? pregnancy; lactation? Chronic inflammatory diseases; major operation in 6 months ago; fiber supplements
Exclusion criteria:
Age minimum:
20 years
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fatty (change of) liver, not elsewhere classified
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Nonalcoholic Fatty Liver Disease.
Fatty (change of) liver, not elsewhere classified
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Intervention(s)
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10 grams of Ocimum Basilicum, 5 grams before lunch and 5 grams before dinner with one glass of water during 3 month.
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Intervention 1: 10 grams of Plantago Psyllium, 5 grams before lunch and 5 grams before dinner with one glass of water during 3 month. Intervention 2: 10 grams of Ocimum Basilicum, 5 grams before lunch and 5 grams before dinner with one glass of water during 3 month. Intervention 3: 10 grams mixed of Ocimum Basilicum and Plantago Psyllium, 5 grams before lunch and 5 grams before dinner with one glass of water during 3 month. Intervention 4: The control group.
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10 grams mixed of Ocimum Basilicum and Plantago Psyllium, 5 grams before lunch and 5 grams before dinner with one glass of water during 3 month.
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10 grams of Plantago Psyllium, 5 grams before lunch and 5 grams before dinner with one glass of water during 3 month.
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The control group.
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Treatment - Other
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Primary Outcome(s)
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Ultrasound finding. Timepoint: first and the end of third month. Method of measurement: ultrasound.
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ALT,AST. Timepoint: first and the end of third month. Method of measurement: blood test.
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Secondary Outcome(s)
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Body compositon. Timepoint: first and the end of third month. Method of measurement: body composition analyser.
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FBS, LDL, HDL, TG, TC. Timepoint: first and the end of third month. Method of measurement: blood test.
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Source(s) of Monetary Support
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Isfahan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Isfahan 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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