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IRCT20170311033004N2 IRCT 2018-08-29 Academic Center for Education, Culture and Research (ACECR) Propolis effects on depressive disorder Evaluation of adjunctive therapy of propolis in the treatment of mild to moderate depression 2018-10-01 anticipated 68 Complete https://irct.ir/trial/25569 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A stratified randomization and Four unit blocks (AABB, ABAB. ABBA & etc.) will be used. The selected stratifies are gender and the used medications. SAS software will perform the randomization process, Blinding description: Placebo and the extract will filled in the same size (00) and same color capsules. The additive filler be applied to make same weight for the both. Only the main applicant are aware about the content of the pills. 2 Depression. Intervention 1: Intervention group: Patients in this group will take a SSIRs anti-dep ression medicine with Propolis (2000mg/70kg) during 6 weeks. Intervention 2: Control group: This group receives the previously prescribed medications and capsules contains placebo (lactose and breadcrumbs as fillers). No - There is not a plan to make this available Justification or reason for not sharing IPD is Results of this project will be published as an article and no individual data sharing is applicable.
public Ali Razmi
Kamalshahr, Jahad daneshgahi research complex
Kamalshahr Iran (Islamic Republic of) 1689734337 +98 26 3476 4015 arazmi@alumnus.tums.ac.ir Academic Center for Education, Culture and Research (ACECR) scientific Ali Razmi
Kamalshahr, Jahad daneshgahi research complex
Kamalshahr Iran (Islamic Republic of) 1689734337 +98 26 3476 4010 arazmi@alumnus.tums.ac.ir Institute of Medicinal Plants (ACECR) Iran (Islamic Republic of) Individuals with diagnosis of mild-moderate depression according HDRS score Age between 18-25 Outpatient Patients with no comorbid disorders diabetes, high blood pressure or cardiovascular disease Patients with no comorbid mental condition No consumption drugs other than SSRI Non-pregnant 18 years 65 years Both Diagnosis of another non-depression disorder for patient during study Suicide inclination Taking anti depression medication except SSRI or electroconvulsive therapy impossibility to track disease (absence at the time of visit, cancellation of the continuation of the study and death) Occurrence of allergic reaction Occurrence of some side effect disorders such as fever, digestive and heart complications due to drug intake Hospitalization F32.0, F32 Depressive episode In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reduction of energy, and decrease in activity. Capacity for enjoyment, interest, and concentration is reduced, and marked tiredness Treatment - Drugs Placebo Intervention group: Patients in this group will take a SSIRs anti-dep ression medicine with Propolis (2000mg/70kg) during 6 weeks Control group: This group receives the previously prescribed medications and capsules contains placebo (lactose and breadcrumbs as fillers). Formulation and primary sample. Timepoint: 6 months. Method of measurement: quantitative. Clinical trials. Timepoint: 22th month. Method of measurement: questionnaire. Academic Center for Education, Culture and Research (ACECR) Approved 2018-06-24 Avicenna Biomedical Research Ethics Committee Darakeh street, Shahid Beheshti university Tehran Tehran Iran (Islamic Republic of)