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IRCT20111105008013N9 IRCT 2020-07-12 Ahvaz University of Medical Sciences clinical trial of effect of Silybum marianum extract capsules on systemic lupus erythematosus patients Double-blinde placebo-controlled clinical trial of effect of Silybum marianum extract capsules on systemic lupus erythematosus patients 2020-07-12 anticipated 70 Complete https://irct.ir/trial/46008 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the permuted block randomization will be used with quadruple blocks. blocks will be produced by using the online site (www.sealedenvelope.com), Blinding description: Unique codes, which is generated by the software, will be used on the drug boxes. By entering each individual into the study based on the produced sequence, the drug box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups. 2-3 Systemic Lupus Erythematosus. Intervention 1: Intervention group: Tab Prednisolone 5 mg/day, tab Methotrexate 2.5 mg/day and tabAzathioprine 50 mg/day (main treatment) with 140 mg Milk thistle capsules 3 times a day for one month. Intervention 2: Control group: Oral Capsules that filled with sugar and starch 3 times per day for one month. Yes - There is a plan to make this available What will be shared: Only a part of data will be shared When: The access period will be 6 months after the publication of the results To whom: The information obtained will only be available to researchers working in universities and science centers Conditions: Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis Where to obtain: Applicants can be contacted with corresponding author by e-mail How to obtain: Applicants will be able to access the obtained data from current study by sending an email to the corresponding author up to one month Comments:
public Amir Siahpoosh
Pharmacognosy grouo, Pharmacy Faculty, Jundishapur University of Medical Science, Golestan, Ahvaz
Ahvaz Iran (Islamic Republic of) 6155883964 +98 61 3334 2197 Amirsiahpoosh@yahoo.com Ahvaz University of Medical Sciences scientific Amir Siahpoosh
جاده گلستان
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3334 2197 Amirsiahpoosh@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) age 18-50 having active lupus 18 years 50 years Both diabetes cardiovascular diseases using irrelevant drugs with lupus pregnancy lactation M32 Systemic lupus erythematosus (SLE) Treatment - Drugs Placebo Intervention group: Tab Prednisolone 5 mg/day, tab Methotrexate 2.5 mg/day and tabAzathioprine 50 mg/day (main treatment) with 140 mg Milk thistle capsules 3 times a day for one month Control group: Oral Capsules that filled with sugar and starch 3 times per day for one month Score of Quality of life questionnaire. Timepoint: At the intervention begining and one month later. Method of measurement: Lupus QOL questionnaire. Score of Systemic Lupus Erythematosus Activity questionnaire. Timepoint: At the intervention begining and one month later. Method of measurement: SLA questionnaire. Side effects. Timepoint: One month after the intervention beginning. Method of measurement: Observation. Ahvaz University of Medical Sciences Approved 2020-02-01 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Esfand St., Farvardin Blvd., Golestan Ahvaz Khouzestan Iran (Islamic Republic of)