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IRCT20161010030255N5 IRCT 2022-06-18 Esfahan University of Medical Sciences Efficacy of Chlorella Vulgaris in Elderly Depressed Patients Efficacy of short term consumption of Chlorella Vulgaris as an additive on severity of depression, anxiety and stress in elderly patients compared to control group 2022-06-22 anticipated 80 Complete https://irct.ir/trial/64053 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who fulfill the required criteria will be selected and will be divided in blocks of two, then they will be sorted based on their national ID number. Based on random numbers the first and second place in each block will be decided. For example for numbers 0-4 the first person will be assorted the letter A and the second person will be assorted the letter B and if numbers 5-9 appear the first person will be assorted the letter B and the second person will be assorted the letter A, Blinding description: Capsules containing Chlorella Vulgaris and placebo are similar in color and are also packed in similar bottles labeled A and B, filled up by an anonymous person unknown to the participants and the research team. اHowever, the participants will be aware of the study process and will enter the study after written consent, but they will not know whether they have received the capsule containing chlorella or placebo until the study ends. 3 Major depression. Intervention 1: Intervention group: Elderly patients aged 60 to 80 years old diagnosed with depression will be treated with 300 - 1200 milligrams of chlorella vulgaris for 12 weeks with their standard anti depressants. As a powder chlorella vulgaris is distributed by Fardaye Sabz Iranian. Intervention 2: Control group: Elderly patients aged 60 to 80 years old diagnosed with depression will be receive 300 - 1200 milligrams of placebo for 12 weeks with their standard anti depressants. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patients information is confidential
public Dr. Victoria Omranifard
EDC, Hezar jarib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8789 v_omranifard@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Victoria Omaranifard
Isfahan university of medical sciences, Hezar jarib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3222 2475 v_omranifard@med.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients within the age range of 60-80 years Reading and writing ability Iranian nationality and ability to speak Persian Living with at least one family member Written consent from patient or family member Diagnosis of major depression based on DSM-V criteria certified by the research director (psychiatrist) that the patient has not been treated for depression at least in the past 4 weeks 60 years 80 years Both Any serious cognitive disorder Developing any unpredictable and undesired physical or mental problem during treatment Consuming Warfarin and chemotherapeutic agents such as; Azathioprine, Basiliximab, Cyclosporine, Daclizumab, Muromonab- CD3, Mycophenolate, Tacrolimus History of drug and alcohol abuse Uncontrolled diabetes or thyroid problem F33.9 Major depressive disorder, recurrent, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Elderly patients aged 60 to 80 years old diagnosed with depression will be treated with 300 - 1200 milligrams of chlorella vulgaris for 12 weeks with their standard anti depressants. As a powder chlorella vulgaris is distributed by Fardaye Sabz Iranian. Control group: Elderly patients aged 60 to 80 years old diagnosed with depression will be receive 300 - 1200 milligrams of placebo for 12 weeks with their standard anti depressants Severity of depression based on Geriatric Depression Scale (GDS). Timepoint: Baseline data, after 6 and 12 weeks. Method of measurement: Persian version of Geriatric Depression Scale (GDS). Severity of depression based on Depression, Anxiety, Stress Scales (DASS). Timepoint: Baseline data, after 6 and 12 weeks. Method of measurement: Persian version of Depression, Anxiety, Stress Scales (DASS). Severity of anxiety based on Depression, Anxiety, Stress Scales (DASS). Timepoint: Baseline data, after 6 and 12 weeks. Method of measurement: Persian version of Depression, Anxiety, Stress Scales (DASS). Severity of stress based on Depression, Anxiety, Stress Scales (DASS). Timepoint: Baseline data, after 6 and 12 weeks. Method of measurement: Persian version of Depression, Anxiety, Stress Scales (DASS). Esfahan University of Medical Sciences Approved 2022-04-26 Ethics committee of Isfahan university of medical sciences No 18, Sepehr complex, Sanayeh dead end, Makine khajoo street, Charbagh khajoo street Isfahan Isfehan Iran (Islamic Republic of)