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IRCT20181028041487N1 IRCT 2019-01-28 Shahed University Evaluation the effect of intra nasal viola odorata almond oil drop on dry eye disease Evaluation the effect of intra nasal viola odorata almond oil drop on dry eye disease 2018-01-21 anticipated 60 Complete https://irct.ir/trial/35071 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are categorized to two groups A&B respectively based on attendance . The first female patient is allocated in group A and the second female patient is allocated in group B. Male patients also are allocated in two groups in a same way, Blinding description: Blinding of drops is done by safety and data supervision committee. Patients (treatment and control group) and the practitioner are blind about the interventions and administered drops. N/A EYE DRYNESS. Intervention 1: Intervention group: They get viola odorata almond oil 2 drops intra nasal for 6 weeks. Both placebo and drug are produced by Traditional medicine research center of Shahed university. Intervention 2: Control group: They get Normal Saline 2 drops intra nasal for 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is پس از اتمام مطالعه تصمیم گرفته خواهد شد
public Dr Jamshid Shayanfar
No. 60 , Shahrak Golestan , Golha Blvd.
Tehran Iran (Islamic Republic of) 1494744415 +98 21 5121 4056 shayanfarj@yahoo.com Shahed University scientific Dr Ali Davati
Beginning of Tehran Qom freeway-Shahed university
Tehran Iran (Islamic Republic of) 33191​18651 +98 21 5121 4056 a_davati@yahoo.com Shahed University Iran (Islamic Republic of) age between 30 to 70 years TBUT<10 s at least in one eye schirmer test < 10 mm at least in one eye without Local anesthesia 2 symptoms of feeling eye dryness , foreign body sensation, eye burning 30 years 70 years Both Any active eye infection Pregnancy or Lactation Any anatomic disorder like entropion or ectropion incoordination of patients important surface diseases of eyes which affects test results History of eye trauma during the past 2 months Moderate to severe blepharitis Refraction surgery or laser therapy of eyes during the past month H04.12 Treatment - Drugs Placebo Intervention group: They get viola odorata almond oil 2 drops intra nasal for 6 weeks. Both placebo and drug are produced by Traditional medicine research center of Shahed university. Control group: They get Normal Saline 2 drops intra nasal for 6 weeks EYE DRYNESS. Timepoint: At the beginning of the study - After 3 weeks - After 6 weeks. Method of measurement: Questionnaire. Shahed University Approved 2017-12-26 Ethics committee of shahed university Beginning of Tehran Qom freeway-Shahed university Tehran Tehran Iran (Islamic Republic of)