Evaluation of mucoadhesive mixture of Nano chitosan-Doxepin dressing in the treatment of oral mucositis

Evaluation of Nano chitosan-Doxepin mucosal dressing in the treatment of oral mucositis: A clinical trial study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20110428006322N4

Enrollment

Registered

2021-12-06

Start date

2021-10-23

Completion date

Unknown

Last updated

2022-01-11

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: Intervention group: chitosan mucoadhesive dressing (Doxepin free) , made by the Department of Pharmaceutical Biotechnology of Shiraz School of Pharmacy, will be prepared in paste form.

Eligibility

Sex/Gender

All

Age

10 Years to 40 Years

Inclusion criteria

Inclusion criteria: Conscious cooperation and satisfaction in attending this study Presence of oral mucositis lesion with greater than or equal to 1 degree (OM= Grade 1) The patient has the appropriate alertness to respond and cooperate with the facilitator No acute respiratory diseases, asthma, diabetes and autoimmune diseases, no fever, active infection No history of doxepin allergy based on patients' history and self-report

Exclusion criteria

Exclusion criteria: Simultaneous use of radiotherapy and chemotherapy Reluctance to use the prepared drug or unwillingness to participate in this plan Absolute neutrophil count (ANC) below 500.

Design outcomes

Primary

Measure	Time frame
In fact, the results of this plan and the mentioned interventions will be examined clinically, by reducing the size of the lesions according to the NCI index, the amount of pain and disability of the patient according to the WHO index and reducing the number of lesions, discoloration and bleeding (WCCNR index). Timepoint: All these clinical indicators on the first, fifth and14th day. An oral health specialist will review the lesions and the healing process at all sessions. Method of measurement: For examination and oral examination of patients, the oral disease specialist performs the examination with headlights or flashlights with the help of conventional examination devices including mirrors or tang blades. The size of the waste will be measured with a calibrated tang blade or caliper. To determine the severity of the disease, three common clinical indicators in similar studies will be used to evaluate clinical efficacy. The NCI index is graded with a score of 0 to 4: Score 0: (without lesions, normal mucosa), score 1: (mucosal erythema), score 2: (isolated pseudomembrane membrane plaque less than 1.5 cm M), score 3: (isolated pseudomembrane membrane plate larger than 1.5 cm), score 4: (deep necrotic wound with unexplained bleeding). The World Health Organization (WHO) scoring system will be used to assess the symptoms and lesions of the oral mucosa, pain and severity of disability, and this index is also shown with a score (Score) between 0 and 4: Score 0: (without lesions And pain), Score 1: (Painless wound or erythema), Score 2: (Painful erythema or wound without eating intervention), Score 3: (Painful erythema or wound with food intervention), Score 4: (Lesion Severe pain that requires immediate supportive treatment). (WCCNR) is another indicator for assessing the status of stomatitis in patients undergoing chemotherapy or radiotherapy. This indicator simultaneously measures the severity of the lesions, the color and the amount of bleeding. . In this index, th	—

Measure

Time frame

In fact, the results of this plan and the mentioned interventions will be examined clinically, by reducing the size of the lesions according to the NCI index, the amount of pain and disability of the patient according to the WHO index and reducing the number of lesions, discoloration and bleeding (WCCNR index). Timepoint: All these clinical indicators on the first, fifth and14th day. An oral health specialist will review the lesions and the healing process at all sessions. Method of measurement: For examination and oral examination of patients, the oral disease specialist performs the examination with headlights or flashlights with the help of conventional examination devices including mirrors or tang blades. The size of the waste will be measured with a calibrated tang blade or caliper. To determine the severity of the disease, three common clinical indicators in similar studies will be used to evaluate clinical efficacy. The NCI index is graded with a score of 0 to 4: Score 0: (without lesions, normal mucosa), score 1: (mucosal erythema), score 2: (isolated pseudomembrane membrane plaque less than 1.5 cm M), score 3: (isolated pseudomembrane membrane plate larger than 1.5 cm), score 4: (deep necrotic wound with unexplained bleeding). The World Health Organization (WHO) scoring system will be used to assess the symptoms and lesions of the oral mucosa, pain and severity of disability, and this index is also shown with a score (Score) between 0 and 4: Score 0: (without lesions And pain), Score 1: (Painless wound or erythema), Score 2: (Painful erythema or wound without eating intervention), Score 3: (Painful erythema or wound with food intervention), Score 4: (Lesion Severe pain that requires immediate supportive treatment). (WCCNR) is another indicator for assessing the status of stomatitis in patients undergoing chemotherapy or radiotherapy. This indicator simultaneously measures the severity of the lesions, the color and the amount of bleeding. . In this index, th

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMostafa Rezaee

Shiraz University of Medical Sciences

rezaim@sums.ac.ir+98 71 3628 9917

Outcome results

None listed

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