Evaluation of Lavandula angustifolia efficacy in treatment of depression in diabetic patients of Shiraz

Promoting quality of life and health of diabetic patients

Eligible patients will be consciously referred to the Shahid Motahari clinic of Shiraz University of Medical Sciences and will be divided into intervention and control groups by block randomization method. The minimum sample size was determined 30 in each group.

The patients will be referred to Shahid Motahari Clinic and after the evaluation of inclusion criteria, they will be assessed by Beck, Pittsburgh and WHO-5 Well-being Index questionnaires and the biochemical parameters will be measured. Then the drugs are given free for 8 weeks. At the end of the study, the questionnaires will be completed and biochemical variables will be measured again and side effects will also be noted.

inclusion criteria: Type 1 or 2 controlled diabetes(70 <FBS <130 and 2hppG <180); Age over 18 years old; A history of over 3 months of depression based on Beck's Questionnaire; Satisfaction of participation; no usage of the drugs which are out of the study protocol; Patients with mild to moderate depression based on the Beck criteria (score less than 28). exclusion criteria: Pregnancy; Lactation; Systemic unstable diseases; having any illness affecting the variables; active suicidal thoughts;

Patients in the intervention group: Sertraline capsule with dosage of 50 mg qhs for 1 week and then 100 mg qhs till the end of the study and a capsule containing 200 mg essential oil of lavender qhs Patients Control group: Sertraline capsule with dosage of 50 mg qhs for 1 week and then 100 mg qhs till the end of the study and a placebo capsule

Change in Beck Depression Inventory Score; The rate of change in Pittsburgh Insomnia Questionnaire score; Change in the WHO-5 Well-being Index Questionnaire score; The rate of change in biochemical variables

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.

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.

Beck Depression , Petersberg insomnia, WHO5 Well Being questionnaire and Biochemical Variables Only part of the data on the primary outcome can be shared.

data will be accessed 6 months after publication of the results

Only available to scholars working in academic institutes

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.

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

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.