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IRCT20140617018126N7 IRCT 2022-11-02 Tabriz University of Medical Sciences The effect of Lavandula angustifolia and Melissa officinalis on depression Evaluation of the effect of Lavandula angustifolia and Melissa officinalis products using nasal spray method on mild to moderate depression 2023-01-21 anticipated 80 Complete https://irct.ir/trial/66309 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization sequences will be done using the random block method with ten blocks, and the intended interventions for each of the four studied groups will be determined in the form of ten-digit codes, through which it will not be possible to recognize the intervention by patients and researchers, and in other words, it will be done double-blind. The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving Melissa officinalis, Lavandula angustifolia, combination of Melissa officinalis and Lavandula angustifolia, and placebo (Assignment). Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). It is worth mentioning that the appearance and smell of all four interventions will be such that it will not be possible to distinguish each one from the other, Blinding description: The intended interventions for each of the four groups will be determined in the form of ten-digit codes. Based on the obtained codes, each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to 80 written on them (according to the order of allocation). The pockets will contain white boxes containing lemongrass spray, lavender, a combination of Melissa officinalis, Lavandula angustifolia, combination of Melissa officinalis and Lavandula angustifolia, and placebo. Only the person in charge of packing will know the numbers of the respective envelopes, and none of the researchers or patients will know the type of intervention that each person receives. The first person will be given pocket number 1 and then it will continue until completion. It is worth mentioning that the appearance and smell of all four interventions will be such that it will not be possible to distinguish each one from the other. 2 Depression. Intervention 1: Intervention group: This group will receive Melissa Officinalis nasal spray containing one percent (one gram per hundred cc) of Melissa Officinalis. The sprays will be provided by Sina Noandish Tabiat Company. Intervention 2: Intervention group: This group will receive Lavandula angustifolia nasal spray containing one percent (one gram per hundred cc) of Lavandula angustifolia. The sprays will be provided by Sina Noandish Tabiat Company. Intervention 3: Intervention group: This group will receive the combination of Melissa Officinalis and Lavandula angustifolia nasal spray containing one percent (one gram per hundred cc) of each plant. The sprays will be provided by Sina Noandish Tabiat Company. Intervention 4: Control group: This group will receive a placebo spray containing the water. The sprays will be provided by Sina Noandish Tabiat Company. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Seyed Mostafa Araj khodaie
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) Having mild to moderate depression Age 18-60 years 18 years 60 years Both History or other psychiatric illness History of allergy to herbal medicines Taking psychiatric or herbal medicines during the last 2 weeks Having severe or chronic medical diseases Pregnant and lactating women History of suicide attempts Having hypothyroidism and high blood pressure F32.1 Major depressive disorder, single episode, moderate Treatment - Other Treatment - Other Treatment - Other Placebo Intervention group: This group will receive Melissa Officinalis nasal spray containing one percent (one gram per hundred cc) of Melissa Officinalis. The sprays will be provided by Sina Noandish Tabiat Company. Intervention group: This group will receive Lavandula angustifolia nasal spray containing one percent (one gram per hundred cc) of Lavandula angustifolia. The sprays will be provided by Sina Noandish Tabiat Company. Intervention group: This group will receive the combination of Melissa Officinalis and Lavandula angustifolia nasal spray containing one percent (one gram per hundred cc) of each plant. The sprays will be provided by Sina Noandish Tabiat Company. Control group: This group will receive a placebo spray containing the water. The sprays will be provided by Sina Noandish Tabiat Company. The level of depression. Timepoint: Week 0, 3 and 6. Method of measurement: Visit by psychiatrist and Hamilton questionnaire. Tabriz University of Medical Sciences Approved 2022-10-10 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)