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IRCT20140617018126N5 IRCT 2021-06-04 Tabriz University of Medical Sciences The effect of Lavandula Angustifolia, Echium amoenum, and Melissa officinalis in comparison with sertraline in the treatment of mild to moderate depression in older adults Evaluation of the effect of Lavandula Angustifolia, Echium amoenum, and Melissa officinalis in comparison with sertraline in the treatment of mild to moderate depression in older adults: A triple-blind randomized controlled trial 2021-08-23 anticipated 120 Complete https://irct.ir/trial/56015 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly assigned to 8 blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into 4 groups of Lavandula Angustifolia and Melissa officinalis, Melissa Officinalis and Echium amoenum, Lavandula Angustifolia and Echium amoenum, and finally sertraline. In the next step, each client will receive white envelopes that are prepared in equal sizes and on which group .. drugs (for the first 10 days of study) and group ... drugs (for the next 46 days) are written. Also, each envelope will be numbered from 1 to 120 (in the order to allocation sequence). Groups ... and ... will have different contents only in the group of patients who will receive sertraline so that group .. contains 12.5 mg sertraline and group ... contains 50 mg of sertraline. Only the person in charge of packing drugs will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine that each person receives. The first person will be given pocket number 1 and then it will continue until completion. Lavandula Angustifolia and Melissa officinalis, Melissa Officinalis and Echium amoenum, Lavandula Angustifolia and Echium amoenum, and sertraline capsules will be similar in shape, size, color and, smell, Blinding description: Based on blocks and allocation sequences each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to120 are written (in order of allocation sequence). The pockets will contain white boxes containing Lavandula Angustifolia and Melissa officinalis, Melissa Officinalis and Echium amoenum, Lavandula Angustifolia and Echium amoenum, and sertraline capsules. Only the person in charge of packing Lavandula Angustifolia and Melissa officinalis, Melissa Officinalis and Echium amoenum, Lavandula Angustifolia and Echium amoenum, and sertraline capsules will know the numbers of the relevant pockets and none of the researchers, patients, or outcome evaluators will know the type of medicine that each person receives. The first person will be given pocket number 1 and then it will continue until completion. All capsules will be similar in shape, size, color, and smell. 3 Depression. Intervention 1: Intervention group: This group will receive one capsule 250mg containing a combination of Lavandula Angustifolia (1 g) and Melissa officinalis (1 g) every 12 hours for two months. The capsules will be provided by َAndisheh Tebe Boali Company. Intervention 2: Intervention group: This group will receive one capsule 250 mg containing a combination of Melissa Officinalis (1 g) and Echium amoenum (500mg), every 12 hours for two months. The capsules will be provided by Andisheh Tebe Boali Company. Intervention 3: Intervention group: This group will receive one capsule of 250mg containing a combination of Lavandula Angustifolia (1 g) and Echium amoenum (500 mg) every 12 hours for two months. The capsules will be provided by Andisheh Tebe Boali Company. Intervention 4: Control group: The group will first receive one capsule 250 mg containing (12.5 mg) of sertraline for first 10 days and then one capsule (50 mg) of sertraline for the next 46 days every 12 hours and for 2 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Mostafa Araj-Khodaei
Aging Research Institute, Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 2178 araj@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mostafa Araj-Khodaei
Aging Research Institute, Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 2178 araj@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 60 years People referring to a psychiatrist with mild to moderate depression who have a depression score of 18 to 24 in the Hamilton questionnaire 60 years 100 years Both No use of antidepressants and antipsychotics and mood-stabilizing nutrients four weeks before the clinical trial Having suicidal ideation Symptoms of major depression Alcohol use in the past 12 months Warfarin and phenytoin use People who have just started psychotherapy People who are pregnant and lactation Taking birth control pills Substance abuse Biological and physical factors such as head trauma, hypothyroidism, dementia, bipolar spectrum, and psychoses Receiving ECT F32.8 Other depressive episodes Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: This group will receive one capsule 250mg containing a combination of Lavandula Angustifolia (1 g) and Melissa officinalis (1 g) every 12 hours for two months. The capsules will be provided by َAndisheh Tebe Boali Company. Intervention group: This group will receive one capsule 250 mg containing a combination of Melissa Officinalis (1 g) and Echium amoenum (500mg), every 12 hours for two months. The capsules will be provided by Andisheh Tebe Boali Company. Intervention group: This group will receive one capsule of 250mg containing a combination of Lavandula Angustifolia (1 g) and Echium amoenum (500 mg) every 12 hours for two months. The capsules will be provided by Andisheh Tebe Boali Company. Control group: The group will first receive one capsule 250 mg containing (12.5 mg) of sertraline for first 10 days and then one capsule (50 mg) of sertraline for the next 46 days every 12 hours and for 2 months. Depression. Timepoint: The first, second, fourth and eighth weeks. Method of measurement: Hamilton Questionnaire. Tabriz University of Medical Sciences Approved 2021-04-26 Ethics committee of Tabriz University of Medical Sciences Research Vice Chancellor, Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)