]>
IRCT20090901002394N40 IRCT 2018-12-18 Iran University of Medical Sciences effect of hesperidin on depression Effects of Hesperidin on serum homocysteine, cortisol and tryptophan kynurenine pathway in major depressive disorder 2018-08-23 anticipated 48 Complete https://irct.ir/trial/33087 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects will be divided into two groups: intervention and placebo (stratified randomization) Based on age (18-40 40-65) Using 4-way permutation blocks and select blocks based on random numbers, Blinding description: Placebo and supplements will be similar in appearance and coded by someone other than the researcher. All investigators, study staff, and participants will be unaware of the allocations. The randomization code will be broken only when the statistical model of the primary and secondary results will be completed. 3 Major Depressive Disorder. Intervention 1: Control group: placebo 500mg daily for 8 week. Intervention 2: Intervention group: hesperidin 500mg daily foe 8 week. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Hadis Sarlak
school of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 hadis_s93@yahoo.com Iran University of Medical Sciences scientific Dr Shima Jazayeri
school of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 sh_jazayeri@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Willing to participate Clinical diagnosis of major depressive disorder; A score ≥15 in the 17-item Hamilton Depression Rating Scale; Age 18 – 65 years; Good health status based on medical history No dietary supplement use during the previous two months No antidepressant or steroid use Absence of benign hormone-sensitive tumors in the ovary, uterus, breast, prostate Not having thoughts about death and suicide Not having any mental illness except anxiety Do not eat citrus more than two units per day 18 years 65 years Both Pregnancy and lactation F32.3 Major depressive disorder, single episode, severe with psychotic features Placebo Treatment - Drugs Control group: placebo 500mg daily for 8 week Intervention group: hesperidin 500mg daily foe 8 week Serum level of cortisol. Timepoint: beginning and end of intervention. Method of measurement: ELIZA. Serum level of homocysteine. Timepoint: beginning and end of intervention. Method of measurement: ELIZA. Serum level of tryptophan. Timepoint: beginning and end of intervention. Method of measurement: ELIZA. Serum level of kynurenine. Timepoint: beginning and end of intervention. Method of measurement: ELIZA. Physical activity. Timepoint: beginning and end of intervention. Method of measurement: IPAQ questionnaire. Energy intake. Timepoint: beginning and end of intervention. Method of measurement: Three-day food record. Iran university of medical sciences Approved 2018-03-01 ethics committee of Iran University of Medical Sciences Shahid Hemmat Highway, next to Milad Hospital, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)