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IRCT20200127046277N1 IRCT 2020-03-26 Esfahan University of Medical Sciences The Efficacy of premedication of PassifloraIncarnata Linnaeus in reducing patients' anxiety Evaluation The Efficacy of premedication of PassifloraIncarnata Linnaeus Compared to placebo on patients' anxiety 2019-09-23 anticipated 78 Complete https://irct.ir/trial/45389 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: For randomization, 26 sheets of number 1 and 26 sheets of number 2 and 26 sheets of number 3 are written (1: Passiflora Incarnata 2: placebo 3: no medication) and patients are asked take out one sheet to write between sheets by chance, Blinding description: In this study, placebo is quite similar to the main drug and therefor patients will be kept unaware of their medication. N/A anxiety. Intervention 1: Intervention group 1: Use of Passiflora-This group will receive the oral premedication of the Passiflora extract. These people will consume 25 drops of the Passiflora extract at the night before the visit and at least 90 minutes before arrival. The therapeutic effects of the Passiflora extract are related to Flavonoids, Alkaloids and sugars. Each 100 ml drop contains about 15 to 15 grams of total flavonoids in terms of hyperoside. The Passiflora extract is produced by Irandarok Pharmaceutical Company. Intervention 2: Intervention group 2: These patients will consume 25 drops of placebo which is completely similar to the extract of the Passiflora , at the night before the visit and at least 90 minutes before the arrival. Intervention 3: Control group: Do not take any medication. 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 No more information.
public Ali Ghazalgoo
Hezarjerib street
Isfahan Iran (Islamic Republic of) 7461766998 +98 31 3792 5547 alighazalgoo@yahoo.com Esfahan University of Medical Sciences scientific Ali Ghazalgoo
No 16; Golha Ave
Isfahan Iran (Islamic Republic of) 7461766998 +98 31 3792 5547 alighazalgoo@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients whose anxiety score is more than 9 based on the Corah questionnaire need root canal therapy 18 years no limit Both Psychotropic drugs usage Liver and blood problems Pregnancy Gastrointestinal diseases F06.4 Anxiety disorder due to known physiological condition Treatment - Drugs Placebo Diagnosis Intervention group 1: Use of Passiflora-This group will receive the oral premedication of the Passiflora extract. These people will consume 25 drops of the Passiflora extract at the night before the visit and at least 90 minutes before arrival. The therapeutic effects of the Passiflora extract are related to Flavonoids, Alkaloids and sugars. Each 100 ml drop contains about 15 to 15 grams of total flavonoids in terms of hyperoside. The Passiflora extract is produced by Irandarok Pharmaceutical Company. Intervention group 2: These patients will consume 25 drops of placebo which is completely similar to the extract of the Passiflora , at the night before the visit and at least 90 minutes before the arrival. Control group: Do not take any medication Anxiety score. Timepoint: The night before treatment and 90 minutes before treatment. Method of measurement: questionnaire Corah’s Dental Anxiety Scale (DAS). Esfahan University of Medical Sciences Approved 2019-12-25 Ethics committee of Isfahan University of Medical Sciences Dental College; Hezarjerib street Isfahan Isfehan Iran (Islamic Republic of)