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IRCT20180416039318N1 IRCT 2018-05-20 Mashhad University of Medical Sciences Effect of Saffron in treatment of Burning Mouth Syndrome Evaluation of the Effectiveness of Crocin of Saffron in treatment of Burning Mouth Syndrome 2018-04-25 anticipated 50 Complete https://irct.ir/trial/30590 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: seal envelope, Blinding description: In this study, the prepared medicine packs are the same for the two groups. Packages are coded from 1 to 40 by an individual outside the study and the mode and duration of consumption are given in the package. Packages are randomly delivered to patients. It should be noted that the psychiatrist, the participants and care providers and assessing outcomes and statistician are unaware of the type of prescribed medicine. 3 Burning Mouth Syndrome. Intervention 1: Intervention group: tablet of Saffron Crocin 15 mg (prepared by a pharmacologist colleague) is prescribed twice daily. Consumption duration is determined to be 11 weeks.The severity of burning, depression, and anxiety of patients are measured and recorded at baseline and intervals of the third, seventh and eleventh week after the beginning. Intervention 2: Control group: Citalopram (Sobhan Darou, Iran) is prescribed once daily. The initial dose is 10 mg and increased to 20 mg after a week. Consumption duration is determined to be 11 weeks. The severity of burning, depression, and anxiety of patients are measured and recorded at intervals of the third, seventh and eleventh week after the beginning. Yes - There is a plan to make this available What will be shared: Some data including demographic properties, signs and symptoms When: two months after article publication. To whom: academic researchers Conditions: It is permitted to use the data in other studies with reference. Where to obtain: Dr Roya Zamani , ZamaniR921@mums.ac.ir How to obtain: sending email to authors. the authors will send data via email during 4 weeks. Comments:
public Roya zamani
Mashhad Dental School, Azadi Square, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 ZamaniR921@mums.ac.ir Mashhad University of Medical Sciences scientific Atessa Pakfetrat
Mashhad Dental School, Azadi Square, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 pakfetrata@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Daily bilateral burning sensation of oral mucosa for at least 4 to 6 months, persistent or increased burning intensity throughout the day, natural oral mucosa in clinical examination and the absence of any local or systemic causes to legitimize the irritation of the mouth, minimum burning intensity of 5 on the VAS scale for patients with BMS, not receiving any antidepressant treatment during the last 4 weeks 15 years 65 years Both the history of systemic disease characterized by burning mouth including diabetes, severe anemia, hypothyroidism, repetitious reflux or a history of micronutrient deficiency , severe psychological disorders such as severe depression, suicide thoughts and the history of hospitalization in psychiatric hospitals, pregnant patients or ones suspected to be pregnant, reports of any susceptibility to drugs or adverse effects, the use of monoamine oxidase inhibitors, tramadol, beta-blockers, benzodiazepines, tricyclic antidepressants at present or the recent month F59 Unspecified behavioural syndromes associated with physiological disturbances and physical factors Treatment - Drugs Placebo Intervention group: tablet of Saffron Crocin 15 mg (prepared by a pharmacologist colleague) is prescribed twice daily. Consumption duration is determined to be 11 weeks.The severity of burning, depression, and anxiety of patients are measured and recorded at baseline and intervals of the third, seventh and eleventh week after the beginning. Control group: Citalopram (Sobhan Darou, Iran) is prescribed once daily. The initial dose is 10 mg and increased to 20 mg after a week. Consumption duration is determined to be 11 weeks. The severity of burning, depression, and anxiety of patients are measured and recorded at intervals of the third, seventh and eleventh week after the beginning. Burning and pain. Timepoint: at baseline and during treatment procedure (intervals of third, seventh and eleventh week after the beginning). Method of measurement: visual analogue scale. Depression and anxiety. Timepoint: 1. at baseline and during treatment procedure (intervals of the third, seventh and eleventh week after the beginning). Method of measurement: Hamilton questionnaire. Mashhad University of Medical Sciences Approved 2015-05-09 Mashhad University of Medical Sciences- Research Ethics Committee Mashhad Dental School, Azadi Square, Vakilabad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)