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IRCT20150309021386N2 IRCT 2018-07-15 Shiraz University of Medical Sciences Effect of Lavender in treatment of depression in diabetic patients Evaluation of Lavandula angustifolia efficacy in treatment of depression in diabetic patients of Shiraz 2018-06-22 anticipated 60 Complete https://irct.ir/trial/32014 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before filling the bottles with either drug or placebo capsule, the they were divided into two equal groups according to the random numbers table. The bottles were then filled with drugs or placebo based on the results obtained, Blinding description: Before filling the bottles with either drug or placebo capsule, the they were divided into two equal groups according to the random numbers table. The bottles were then filled with drugs or placebo based on the results obtained. Only the researcher can decode the contents of each bottle based on the original form of the randomization. The person responsible for the delivery of the drug, the patient, the physician, and the person responsible for evaluating the consequences, will not be informed of the coding . The results of the control and intervention groups under the headings A and B will be delivered to the statistical analyst. N/A Condition 1: Depression. Condition 2: Diabetes Mellitus. Condition 3: Diabetes Mellitus. Intervention 1: Intervention group: Sertraline capsule qhs with dosage of 50 mg for 1 week and then 100 mg till the end of the study plus one gelatin capsule containing 200mg of lavender essential oil qhs. Intervention 2: Control group: Sertraline capsule qhs with dosage of 50 mg for 1 week and then 100 mg till the end of the study plus one placebo capsule qhs. Yes - There is a plan to make this available What will be shared: Beck Depression , Petersberg insomnia, WHO5 Well Being questionnaire and Biochemical Variables Only part of the data on the primary outcome can be shared. When: data will be accessed 6 months after publication of the results To whom: Only available to scholars working in academic institutes Conditions: Only part of the documentation can be provided to scholars from academic and clinical centers and with official permission from Shiraz University of Medical Sciences. Where to obtain: Vice Chancellor of Research Postal Address: Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Postal Code: 71345-1978 Tel: +98 71 32357282 Fax: +98 71 32307594 E-mail: vcrdep@sums.ac.ir How to obtain: After sending the request to the Vice-Chancellor for Research of Shiraz University of Medical Sciences, this request will be assessed and if approved by the relevant vice president, the planner will be informed to disseminate the data. Then the data will be provided to him. Comments:
public Mohadeseا Ostovar
Medical faculty, Zand St.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5886 ostovarm@sums.ac.ir Shiraz University of Medical Sciences scientific Mojtaba Heydari
Medical faculty, Zand St.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5886 mheydari@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Type 1 or 2 diabetes mellitus that is controlled (70 <FBS <130 and 2hppG <180) • Age over 18 years old• Over 3-months history of depression based on Beck's questionnaire • Satisfaction with participating in the study • No usage of out-of-study protocol treatments (all anti-depressant drugs (TCA, SSRI, SNRI, etc.) and medicinal herbs affecting mood such as bell peppermint, valerian fever, and lemon balm, etc.) • Patients who have mild to moderate depression based on the Beck criteria (score less than 28) 18 years no limit Both Pregnancy, Lactation, Systemic unstable diseases (liver, thyroid, cardiovascular, renal dx), Active suicidal thoughts F32.1 E11 E10 Major Depressive Disorder, single episode, moderate Type 2 Diabetes Mellitus Type 1 Diabetes Mellitus Treatment - Drugs Placebo Intervention group: Sertraline capsule qhs with dosage of 50 mg for 1 week and then 100 mg till the end of the study plus one gelatin capsule containing 200mg of lavender essential oil qhs Control group: Sertraline capsule qhs with dosage of 50 mg for 1 week and then 100 mg till the end of the study plus one placebo capsule qhs. Change in Beck Depression Inventory Score. Timepoint: At The Beginning And at The End of The Study. Method of measurement: Beck Depression Questionnaire. Pittsburgh Insomnia Questionnaire. Timepoint: At The Beginning and at The End of The Study. Method of measurement: Pittsburgh Insomnia Questionnaire. Change of WHO-5 Well-being Index Questionnaire Score. Timepoint: At The Beginning and at The End of The Study. Method of measurement: WHO-5 Well-being Index Questionnaire. Change of Biochemical Variables. Timepoint: At The Beginning and at The End of The Study. Method of measurement: Laboratory Data. Shiraz University of Medical Sciences Approved 2018-06-18 Ethics committee of Shiraz University of Medical Sciences Zand street Shiraz Fars Iran (Islamic Republic of)