]>
IRCT20190811044513N2 IRCT 2020-03-02 Hamedan University of Medical Sciences Examination of the effect of silybum marianum on thyroid and antioxidant capacity in patients with bipolar disorders under the treatment of lithium Examination of the effect of silybum marianum on thyroid and antioxidant capacity in patients with bipolar disorders under the treatment of lithium 2019-09-22 anticipated 40 Complete https://irct.ir/trial/41488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose we will use quadratic random blocks method. For this purpose, we provide four sheets of paper for each drug and placebo group separately. We write on two sheets of letter A (intervention group) and on the other two sheets of letter C (comparison group). Mix the sheets together and place in a drawer. By referring to each eligible patient, one sheet was randomly drawn and the A or C sheet was drawn according to one of the two groups (silybum recipient) and control group Will be allocated. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been drawn. Once the four sheets have been randomly pulled out, all the sheets are returned to the drawer and the procedure will be repeated for the next four patients until the desired sample size is reached, Blinding description: Patients were randomly divided into either drug or placebo groups. Both groups receive standard treatment with lithium and anti-psychotic drugs. In the drug group, in addition to the standard treatments for depression in bipolar depression, silybum is used at a dose of 140 mg daily for 10 weeks. In the placebo group, along with standard treatments, placebo is similar in appearance to the drug for 10 weeks. In this study, the researcher and treating physician who will examine patients will not be aware of the type of medication used for patients. Therefore, this study will be a double blind study. 3 Patients with bipolar disorder. Intervention 1: Intervention group: The intervention group received 16 mg daily silymarin in addition to standard treatments effective in the depression phase of bipolar disorder. Intervention 2: Control group: The placebo or control group received placebo for 16 weeks in addition to standard treatments. 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 I haven't decided yet
public Sara Ataei
Faculty of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmide Ave
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1591 s.ataei@umsha.ac.ir Hamedan University of Medical Sciences scientific Sara Ataei
Faculty of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmide Ave
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1591 s.ataei@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age group 18 to 70 years Patients with diagnosis of bipolar depression disorder by a psychiatrist based on DSM-5 Patients who receiving lithium 18 years 70 years Both Patients with mixed depressive phase with simultaneous manic or hypomanic Pregnant patients Lactating patients F31 Bipolar disorder Treatment - Drugs Placebo Intervention group: The intervention group received 16 mg daily silymarin in addition to standard treatments effective in the depression phase of bipolar disorder. Control group: The placebo or control group received placebo for 16 weeks in addition to standard treatments. Thyroid markers. Timepoint: Before the intervention and 16 weeks after the intervention. Method of measurement: Using the ELISA method. Serum antioxidant capacity. Timepoint: Before the intervention and 16 weeks after the intervention. Method of measurement: Using the Colorimetric Kit. The mean of liver parameters. Timepoint: Before intervention and 16 weeks after the intervention. Method of measurement: Using a special kit. Blood lithium level. Timepoint: Before intervention and 16 weeks after the intervention. Method of measurement: By the fluorometric method. Depression Phase Bipolar Disease. Timepoint: Before intervention and 16 weeks after the intervention. Method of measurement: Patient symptoms and physician diagnosis. Hamedan University of Medical Sciences Approved 2019-12-20 Ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Fhahid fahmide Ave Hamdan Hamadan Iran (Islamic Republic of)