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IRCT2015031521469N1 IRCT 2015-06-03 Vice chancellor for research, Shiraz University of Medical Science Efficacy of Nepeta Menthoides in depression Comparison of the efficacy of Nepeta mentoithes Boiss & Bohse and a common anti depressant drug (Sertraline) in mild to moderate major depression 2015-04-07 anticipated 60 Complete https://irct.ir/trial/18805 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: Blocked randomization; Blinding with use of Sertraline in the same capsules for control group, all capsules are similar in size and colour, boxes in which capsules pack have the same shape in both groups. Patients and researcher who evaluate study out comes and even though the data analyzer are blind and do not know which group receives Sertraline or Nepeta . 3 Condition 1: Depression. Condition 2: Anxiety. Intervention 1: One 400 mg oral capsule from Nepeta menthoides aerial parts freeze-dried water extract (extract concentration, 10%), twice daily (one in morning half hour before breakfast and one at night 1-2 hour before usual sleep time) for one month. Intervention 2: Serteraline (Sertrabiol manufactured by Bakhtar Bioshimi Co.) , 50 mg in each capsule, one capsule twice daily.
public Sepideh Koloury
Traditional Persian Medicine college, School of Medicine, Imam Hossein Sq., Zand St., Shiraz
Shiraz Iran (Islamic Republic of) 7194647989 +98 71 3233 7589 kolouri@sums.ac.ir, sepidehkolouri@yahoo.com Shiraz University of Medical Science scientific Ali Firoozabadi
Shiraz Department of psychiatry, Hafez hospital, Chamran Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 71946-34786 +98 71 3627 9319 firooza@sums.ac.ir Shiraz University of Medical Science Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Adult outpatients between 18-65 referring to psychiatry clinic of Shiraz medical university; meet Becks depression inventory (BDI-II) and DSM-V-TR criteria for mild to moderate major depression; confirmation of the diagnosis by at least two psychiatrist; and informed consent. Exclusion criteria: Having other conditions assuming depression such as: hypothyroidism, psychiatric disorders except for mild to moderate major depression, mental disorders i.e. dementia or mental retardation; allergy to Nepeta Menthoides or other mentheae family (Lamiaceaes); substance dependency; pregnancy; suicidal thinking or needing to electroconvulsive therapy; not having informed consent 18 years 65 years Both F32.0, F32 F41 Mild depressive episode, moderate depressive episode, recurrent depressive disorder current episode mild, recurrent depressive disorder current episode moderate Other anxiety disorders Treatment - Drugs Treatment - Drugs One 400 mg oral capsule from Nepeta menthoides aerial parts freeze-dried water extract (extract concentration, 10%), twice daily (one in morning half hour before breakfast and one at night 1-2 hour before usual sleep time) for one month Serteraline (Sertrabiol manufactured by Bakhtar Bioshimi Co.) , 50 mg in each capsule, one capsule twice daily Severity of depression. Timepoint: At the base line,2nd week, 4th week after beginning of intervention and then in 6th week (2 weeks after the end of intervention). Method of measurement: Beck depression inventory(BDI-II) score. Side effects profile. Timepoint: At the base line, 2nd week, 4th week after beginning of intervention and then in 6th week (2 weeks after the end of intervention). Method of measurement: Clinical interview and physical examination and list in a table. Severity of anxiety. Timepoint: At the base line, 2nd week, 4th week after beginning of intervention and then in6th week (2 weeks after the end of intervention). Method of measurement: Beck anxiety inventory (BAI) score. CT- 9470 - 7440 Iranian Registry of Clinical Trial Vice chancellor for research, Shiraz University of Medical Science Approved 2015-04-07 Ethic committee of Shiraz University of Medical Science Vice chancellor for research and technology office, Shiraz University of Medical Science, Zand street,Shiraz Shiraz Iran (Islamic Republic of)