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Effectiveness of licorice and triamcinolone acetonide muco-adhesive films on mucositis

Evaluation of the effectiveness of licorice mucoadhesive film and triamcinolone acetonide mucoadhesive film on symptoms of head and neck radiotherapy-induced mucositis in comparison with placebo

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200303046685N1
Enrollment
90
Registered
2020-06-29
Start date
2019-12-11
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

oral mucositis. Oral mucositis (ulcerative) due to radiation

Interventions

Intervention 1: Intervention group 1: Licorice mucoadhesive film, with Aphthogel brand name, made by Dr Saniee Pharmaceutical Company, locally applied on upper lip mucosa, after each meal and once bef

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with radiotherapy induced oral mucositis Age above 18 years Non-pregnant women Patient willingness to remain in the study

Exclusion criteria

Exclusion criteria: History of drug abuse that interferes with the treatment procedure in the researcher’s point of view simultaneous treatment with another drug allergy or intolerance to corticosteroids inability to provide informed consent high blood pressure active gastric ulcer liver disease, neural disease Endocrine disorders or other significant systemic diseases that make it difficult to implement the protocols or test the results

Design outcomes

Primary

MeasureTime frame
Mucositis Grade. Timepoint: At the beginning of the study and at days 7,14 and 21. Method of measurement: WHO mucositis assessment scale.

Secondary

MeasureTime frame
Oral pain. Timepoint: At the beginning of the study and at days 7,14 and 21. Method of measurement: VAS ( visual analogue scale).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahimeh pakravan

Esfahan University of Medical Sciences

pakravan@dnt.mui.ac.ir+98 31 3436 8793

Outcome results

None listed

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