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Effect of Saffron in treatment of Burning Mouth Syndrome

Evaluation of the Effectiveness of Crocin of Saffron in treatment of Burning Mouth Syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180416039318N1
Enrollment
50
Registered
2018-05-20
Start date
2018-04-25
Completion date
Unknown
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning Mouth Syndrome. Unspecified behavioural syndromes associated with physiological disturbances and physical factors

Interventions

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

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya zamani

Mashhad University of Medical Sciences

ZamaniR921@mums.ac.ir+98 51 3882 9501

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026