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Comparison the effect of Aloe Vera and Benzydamine hydrochloride mouth rinses on mucositis caused by radiation

Comparison of aloe vera mouthwash and and Benzydamine Hydrochloride mouthwash on radiation induced mucositis in patients with head and neck cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012072410377N1
Enrollment
26
Registered
2012-11-16
Start date
2012-07-10
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Mucositis. Acute radio dermatitis

Interventions

Intervention 1: Intervention: Aloe vera mouth rinse, chemical composition: Aloe vera gel 100%, concentration of 0.0009% Blue color Brilliant Blue, concentration of 0.0006% yellow color Tarterazine, ma
Prevention
Intervention: Aloe vera mouth rinse, chemical composition: Aloe vera gel 100%, concentration of 0.0009% Blue color Brilliant Blue, concentration of 0.0006% yellow color Tarterazine, manufacturer: Bary
Control: Benzydamine hydrochloride Mouth rinse, chemical composition: Benzydamine hydrochloride 0/15 %, manufacturer: pharmaceutical company Behvazan, brand: Behvazan 0/15% - During 6 weeks of Radioth

Sponsors

Baryj Essence Pharmaceutical Company
Lead Sponsor
Vice chancellor for research, school of Dentistry Tehran University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Minimum age: 18 years, diagnosed cancer in the head and neck region, the minimum therapeutic dose of 50 Gy, oral cavity is placed in the radiation field, the patient's ability to cooperate and use medications as directed. Exclusion criteria: Patients with a history of cancer treatment during the last year, patients with a history of food allergy, oral lesions including active infection, mouth ulcers before starting the radiation therapy, lack of patient willingness and cooperation to participate in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mucositis grade. Timepoint: From Starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: questionnaire based on the Mucositis grade rating items from the World Health Organization (WHO).

Secondary

MeasureTime frame
Mouth soreness. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Asking from patient).;Ulcer. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Observation).;Disability to swallowing solid food. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Asking from patient).;Disability to alimentation. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Asking from patient).;Erythema. Timepoint: From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment. Method of measurement: Questionnaire (Asking from patient and observation).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDoctor Arash Mansourian

School of Dentistry Tehran University of Medical Sciences, oral medicine Department

aMansourian@tums.ac.ir+98 21 8835 1152

Outcome results

None listed

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