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IRCT20200607047672N1 IRCT 2020-12-27 Iran University of Medical Sciences Effect of curcumin in depression Effect of curcumin on cognitive function and inflammatory index in people affected by major depression 2018-07-23 anticipated 120 Complete https://irct.ir/trial/49364 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among the patients with MDD referred to medical centers, 120 people were selected by criterion sampling method based on inclusion and exclusion criteria and were randomly assigned to two groups A and B based on a table of random numbers. Then A and B groups were assigned to be curcumin and active control groups randomly, Blinding description: Participants, principal investigators, paraclinical colleagues of the project, data analysts did not know which group A or B was the test or control. Both groups were treated with sertraline. In the control group, placebo was used, which was completely similar in color, weight and size to the curcumin capsule. 3 Major Depression. Intervention 1: Intervention group: Sertraline 50 mg and curcumin 1000 mg so that in the first four days of sertraline 25 mg, then 50 mg sertraline until the end of the intervention. Curcumin at a dose of 1000 mg daily was added to the standard treatment in divided doses of 500 mg in the morning and at noon with water. Intervention 2: Control group: sertraline 50 mg and placebo. In the first four days, sertraline received 25 mg, then 50 mg sertraline until the end of the intervention. Placebo (roasted rice powder) at a dose of 1000 mg per day, divided into It was added to the standard treatment in two doses of 500 mg in the morning and at noon with water. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after individuals become unidentifiable When: available after 6 months of publication To whom: Researchers working in academic and scientific institutions Conditions: Academic and scientific research cases Where to obtain: Dr Zeynab Ali madadi zeinabalimadadi@gmail.com or hoshiar psychological center Dr Aaeed Azami sa.azamy@gmail.com 00989124758909 How to obtain: Send email to the responsible author. Authentication documents certified by the applicant or the relevant research center must be sent. Specify how and with what intention the information will be used. according to this instruction, data access, treatment protocol, data analysis map and clinical study report will be available within two working weeks. Comments:
public Zeynab Ali madadi
n13 hamid avn, shariati st
Tehran Iran (Islamic Republic of) 1639666355 +98 21 8862 4617 zeinabalimadadi@gmail.com Iran University of Medical Sciences scientific Zeynab Alimadadi
n13 hamid ave, shariatii st
Tehran Iran (Islamic Republic of) 1639666355 +98 21 8862 4617 zeinabalimadadi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) diagnosis of major depression by psychiatrist no history of drug abuse no history of endocrinological disorders no history of immune dysfunction disorders no history of other CNS disorders not obese not being on any type of dieting no suicidal idea no psychosis not using antidepressant medications for last three months not using anti inflammatory medications not using unprescribed medicine speaking Persian fluently ability to write Persian not pregnant 18 years 65 years Both history of drug abuse endocrinological disorders immune dysfunction disorders other CNS disorders obesity using a special form of diet suicide idea psychosis using antidepressant medications for last three months using anti inflammatory medications using unprescribed medicine pregnancy F33 Major depressive disorder, recurrent Treatment - Drugs Treatment - Other Intervention group: Sertraline 50 mg and curcumin 1000 mg so that in the first four days of sertraline 25 mg, then 50 mg sertraline until the end of the intervention. Curcumin at a dose of 1000 mg daily was added to the standard treatment in divided doses of 500 mg in the morning and at noon with water. Control group: sertraline 50 mg and placebo. In the first four days, sertraline received 25 mg, then 50 mg sertraline until the end of the intervention. Placebo (roasted rice powder) at a dose of 1000 mg per day, divided into It was added to the standard treatment in two doses of 500 mg in the morning and at noon with water. Speed processing time in trail making task A. Timepoint: At beginning, after 6 weeks and12 weeks. Method of measurement: trail making task A. Speed processing time in trail making task B. Timepoint: At beginning, after 6 weeks and12 weeks. Method of measurement: trail making task B. Executive function score on verbal fluency task. Timepoint: At beginning, after 6 weeks and12 weeks. Method of measurement: verbal fluency task. Executive function score on Wisconsin sorting test. Timepoint: At beginning, after 6 weeks and12 weeks. Method of measurement: Wisconsin sorting test. Serum level of interleukin 1 beta. Timepoint: At the beginning and week 12. Method of measurement: Serum test, Enzyme linked Immuno Assay ,ELISA. Serum level of interleukin 6. Timepoint: At the beginning and week 12. Method of measurement: Serum test, Enzyme linked Immuno Assay ,ELISA. Serum level of high sensitivity C reactive protein. Timepoint: At the beginning and week 12. Method of measurement: Serum test, Enzyme linked Immuno Assay ,ELISA. Executive function score on Tower of London Test. Timepoint: At beginning, after 6 weeks and12 weeks. Method of measurement: Tower of London Test. Iran University of Medical Sciences Approved 2017-05-04 Ethics committee of Iran University of medical sciences n13, hamid Ave,Shariatii St, north to motahari St Tehran Tehran Iran (Islamic Republic of)