Assessment of natural honey oral gel for the prevention of chemotherapy induced oral sorness

Assessment of formulation of natural honey for the prevention of chemotherapy induced oral mucositis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201506063106N25

Enrollment

Registered

2015-06-12

Start date

2015-05-22

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

Oral mucositis. Oral Mucositis(ulcerative

Interventions

Intervention 1: interventional group: are patients whit similar protocol for control group(the oral care and rinsing normal saline)but supplied whit our formulation two to four times a day from the fi

Prevention

interventional group: are patients whit similar protocol for control group(the oral care and rinsing normal saline)but supplied whit our formulation two to four times a day from the first day of study

Control group are patients whit the oral care and rinsing salin that prescribed by the dentist specialized in oral deases and healths.

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: being adult female diagnosed breast cancer;new patient under chemotherapy regimen wich induce oral mucositis;not pregnant and lactating;have a normal oral cavity examination;no diabetes;no renal and liver disorders;and no sensitivity to active ingrediants. Exclusion criteria: sensitivity or intolerability to the formulation;unwillingness to take apart in study;developing of severe mucositis or acute other oral complications.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Oral mucositis. Timepoint: Daily and every two or tree weeks. Method of measurement: Self-assessment questionnaire and WHO grading and oral examination.;Pain in the oral cavity. Timepoint: Daily. Method of measurement: self-assessment questionnaire.;Speech. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Oral ulcers. Timepoint: Daily and every two or tree weeks. Method of measurement: Self-assessment quesionnaire and WHO grading and oral examination.;Eating solid and semisolid food. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Saliva changes. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Drinking. Timepoint: Daily. Method of measurement: Self-assessment quesionnaire.;Swallowing. Timepoint: daily. Method of measurement: Self-assessment questionnaire.;Taste changes. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Gingival bleeding and discomfort. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Burning in the oral cavity. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Erythema in the oral cavity. Timepoint: Daily. Method of measurement: Self-assessment questionnaire and oral examinaion and WHO grading.;Unusual color in the oral cavity. Timepoint: Daily. Method of measurement: Self-assessment questionnaire and oral examination and WHO grading.;Infection in the oral cavity. Timepoint: daily and every two or tree weeks. Method of measurement: Self-assessment questionnaire and oral examination.;Using pain killer for oral complications. Timepoint: daily. Method of measurement: Self-assessment questionnaire.;Duration of mucositis. Timepoint: Every two or tree weeks. Method of measurement: Self-assessment questionnaire.	—

Measure

Time frame

Oral mucositis. Timepoint: Daily and every two or tree weeks. Method of measurement: Self-assessment questionnaire and WHO grading and oral examination.;Pain in the oral cavity. Timepoint: Daily. Method of measurement: self-assessment questionnaire.;Speech. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Oral ulcers. Timepoint: Daily and every two or tree weeks. Method of measurement: Self-assessment quesionnaire and WHO grading and oral examination.;Eating solid and semisolid food. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Saliva changes. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Drinking. Timepoint: Daily. Method of measurement: Self-assessment quesionnaire.;Swallowing. Timepoint: daily. Method of measurement: Self-assessment questionnaire.;Taste changes. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Gingival bleeding and discomfort. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Burning in the oral cavity. Timepoint: Daily. Method of measurement: Self-assessment questionnaire.;Erythema in the oral cavity. Timepoint: Daily. Method of measurement: Self-assessment questionnaire and oral examinaion and WHO grading.;Unusual color in the oral cavity. Timepoint: Daily. Method of measurement: Self-assessment questionnaire and oral examination and WHO grading.;Infection in the oral cavity. Timepoint: daily and every two or tree weeks. Method of measurement: Self-assessment questionnaire and oral examination.;Using pain killer for oral complications. Timepoint: daily. Method of measurement: Self-assessment questionnaire.;Duration of mucositis. Timepoint: Every two or tree weeks. Method of measurement: Self-assessment questionnaire.

—

Secondary

Measure	Time frame
Investigational product side effects. Timepoint: Every two or tree weeks. Method of measurement: Self-assessment questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mehdi Rajabi

Pharmaceutical science branch of Islamic Azad university

mehdirj@aol.co.uk+98 21 2246 0056

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026