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IRCT20191006044993N1 IRCT 2019-11-05 Iran University of Medical Sciences Effect of Plantago major on nonalcoholic fatty liver disease Comparison of the effect of plantago major with placebo on liver enzymes in patients with nonalcoholic fatty liver disease(NAFLD): a double-blind randomized clinical trial 2019-10-23 anticipated 80 Complete https://irct.ir/trial/42817 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is used using 4-way blocks and a random number table.Interventions A and B define six blocks of four.Using random numbers, we select and write blocks. Each individual is then assigned to an A or B intervention. For allocation concealment, sealed envelopes are used, so that the individual number is written on the envelope and the treatment group inside the envelope, Blinding description: The drug and placebo are coded in similar capsules and in identical packages, with the same color and aroma, and the patient, clinician, and researcher are unaware of how the drug or placebo is coded. 2-3 Non Alcoholic Fatty Liver Disease. Intervention 1: Intervention group:In the intervention group in addition to lifestyle training and in-person follow-up once every 2 weeks, the 500 mg capsule of Plantago major seed twice per day is given, 2 capsules each time, orally for 12 weeks.The seeds of Plantago major are planted and placed in 500 mg capsules in the laboratory of the Faculty of Traditional Medicine. Intervention 2: Control group:In the intervention group in addition to lifestyle training and in-person follow-up once every 2 weeks, the 500 mg capsule of toasted flour twice per day is given, 2 capsules each time, orally for 12 weeks.After preparation, the bread powder was placed in 500 mg capsules in the laboratory of the Faculty of Traditional Medicine. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Seyede Ferdos Jazayeri
No. 167,Mojahedine Eslam Ave.,Behnam Towers
Tehran Iran (Islamic Republic of) 1154838346 +98 21 7752 1303 sf.jazayeri46@gmail.com Iran University of Medical Sciences scientific Seyede Ferdos Jazayeri
No. 167,Mojahedine Eslam Ave.,Behnam Towers
Tehran Iran (Islamic Republic of) 1154838346 +98 21 7752 1303 sf.jazayeri46@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Sono graphic report of Grade 1 and 2 fatty liver Increase in ALT> 40 Increase in AST>38 Ages 12 to 80 years 12 years 80 years Both The patient's unwillingness to participate in the scheme Pregnancy & lactation Anti coagulant drugs consumption Thyroid diseases Spleen diseases Cirrhosis ,viral hepatitis and obstructive liver disese Treated dyslipidemia Overt Diabetes mellitus Lung diseases Taking any medication that affects liver metabolism and enzymes, including oral contraceptives, corticosteroids, salazines, etc. K76-0 Non Alcoholic Fatty Liver Disease Treatment - Drugs Placebo Intervention group:In the intervention group in addition to lifestyle training and in-person follow-up once every 2 weeks, the 500 mg capsule of Plantago major seed twice per day is given, 2 capsules each time, orally for 12 weeks.The seeds of Plantago major are planted and placed in 500 mg capsules in the laboratory of the Faculty of Traditional Medicine. Control group:In the intervention group in addition to lifestyle training and in-person follow-up once every 2 weeks, the 500 mg capsule of toasted flour twice per day is given, 2 capsules each time, orally for 12 weeks.After preparation, the bread powder was placed in 500 mg capsules in the laboratory of the Faculty of Traditional Medicine. Comprison of the Plantago major seed with Placebo on ALT enzyme(Alanin trasaminase) in Non Alcoholic Fatty Liver Disease (NAFLD). Timepoint: Onset, 6th and 12th week of study.(End of study). Method of measurement: Hitachi 912 instrument. Comprison of the Plantago major seed with Placebo on AST enzyme(Aspartate transaminase) in Non Alcoholic Fatty Liver Disease (NAFLD). Timepoint: Liver enzymes measurement at baseline, 6th and 12th weeks (end of study). Method of measurement: Hitachi 912 instrument. Iran University of Medical Sciences Approved 2019-07-20 Ethics committee of Iran University of Medical Sciences No. 167,Mojahedine Eslam Ave.,Behnam Towers Tehran Tehran Iran (Islamic Republic of)