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IRCT20141025019669N17 IRCT 2021-03-22 Mazandaran University of Medical Sciences The effect of gallic acid supplementation in patients with major depression The effect of oral gallic acid supplementation on antioxidant status in people with major depression 2021-04-04 anticipated 60 Complete https://irct.ir/trial/54531 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to trial groups (intervention and placebo groups) randomly using Random Allocation Software (RAS) through random block sizes of 4 and 6 with an allocation ratio of 1:1. Patients will receive a sealed container of supplements. Random sequencing allocation will be produced by the person who has not participate in the research. Containers will be numbered from 1 to 60 according to the sequence generated, Blinding description: Supplements and placebo will be placed in similar containers and will be coded by someone other than the researcher, so patients and the investigator will be blinded to medicine and placebo groups. 3 Major depressive episode. Intervention 1: Intervention group: Gallic acid, a capsule 200 mg per daily for two months, Manufacturer: Supplement Spot. Intervention 2: Control group: A daily placebo capsule containing wheat flour for two months. Yes - There is a plan to make this available What will be shared: All data after people are unrecognizable When: After completing the study and publishing the article To whom: All researchers Conditions: There is no objection to the use of data provided the source of the resource. Where to obtain: By contacting the email address of a person responsible for general inquiries khademnut@yahoo.com How to obtain: After publishing the article Comments:
public Gholamreza Houshmand
No 8, Zabihi buildig, Niloufar Alley, Farah Abad blvd, Khazar Square, Sari
Sari Iran (Islamic Republic of) 481751665 +98 11 3354 3081 g.houshmand@mazums.ac.ir Mazandaran University of Medical Sciences scientific Hossein Khadem Haghighian
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
Qazvin Iran (Islamic Republic of) 59811 -34197 +98 28 3333 6001 khademnut@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Men and women with Major Depressive Willingness to work Age 18- 55 Non-modification of treatment and medications for at least the past 2 months 18 years 55 years Both Pregnancy and breastfeeding Patients with severe renal and hepatic dysfunction Alcohol consumption F32 Major depressive disorder, single episode Treatment - Drugs Treatment - Drugs Intervention group: Gallic acid, a capsule 200 mg per daily for two months, Manufacturer: Supplement Spot Control group: A daily placebo capsule containing wheat flour for two months Severity of depression. Timepoint: Before the intervention and after the intervention. Method of measurement: Hamilton Rating Scale. Total antioxidant capacity. Timepoint: Before the intervention and after the intervention. Method of measurement: Eliza. Malondialdehyde. Timepoint: Before the intervention and after the intervention. Method of measurement: Eliza. Mazandaran University of Medical Sciences Approved 2020-09-16 Ethics Committee of Mazandaran University Of Medical Sciences Vice chancellor for research, Moallem Square, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)