Effect of Saffron in treatment of Burning Mouth Syndrome
- Conditions
- Burning Mouth Syndrome.Unspecified behavioural syndromes associated with physiological disturbances and physical factors
- Registration Number
- IRCT20180416039318N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.