MedTrace Logo

Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Prevention of Pain and Progression of Radiation-induced Oral Mucositis

NCT06862817 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-06

No results posted yet for this study

Summary

Oral mucositis, a painful inflammation and ulceration of the mucous membranes in the mouth, is commonly seen in patients undergoing chemotherapy or radiation therapy. Effective management of this condition is crucial to reduce pain, promote healing, and maintain oral function.

Benzydamine mouth gel is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties, making it useful in treating oral mucositis. It works by blocking pain and reducing inflammation, helping to relieve symptoms like soreness and swelling. Studies suggest that benzydamine gel can decrease the severity of mucositis, ease discomfort, and improve patients' quality of life.

Aloe vera gel is well-known for its soothing, anti-inflammatory, and wound-healing properties. When applied to oral mucositis lesions, it promotes healing by providing hydration and forming a protective barrier over the affected tissue. Aloe vera's natural compounds, such as glycoproteins and polysaccharides, help in pain relief and accelerate tissue repair, making it a complementary option to reduce mucositis severity.

Together, benzydamine and aloe vera gels can be effective in managing oral mucositis. Benzydamine offers immediate pain relief and reduces inflammation, while aloe vera aids in longer-term healing and tissue regeneration. This combination approach has shown promise in enhancing comfort and accelerating recovery for patients with mucositis.

Conditions

  • Radiation Indused Oral Mucositis

Interventions

DRUG

Aloe vera gel

Aloe vera mouthgel not only as a potent agent for prevention mucositis, but also as a prevention of candidiasis in patients undergoing radiotherapy of head and neck with its antifungal and immunomodulation properties

DRUG

Benzydamine Hydrochloride 0.15% Oral gel

. Benzydamine's mechanisms of action are rooted in its anti-inflammatory, anesthetic, and analgesic properties. It has been shown to reduce the synthesis of TNF-α, IL-1β and prostaglandins while also acting as an antioxidant by scavenging reactive oxygen species (ROS) benzydamine inhibits leukocyte-endothelial interactions, thereby decreasing neutrophil degranulation, and helps mitigate histamine-induced vasodilation and vascular permeability.

DRUG

bioadhesive gel

bioadhesive These polymers increase viscosity through a liquid-to-semi-solid phase transition, improving retention at the administration site and providing a sustained release profile ,Mucoadhesive Dosage Forms These dosage forms are typically employed to administer medications to epithelial surfaces, including the buccal cavity, sublingual area, oral cavity, eyes, nasal passages, vagina, and lungs

Sponsors & Collaborators

  • Faculty of Medicine, Minia University

    collaborator UNKNOWN

  • Minia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-04-11
Completion
2024-06-15

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862817 on ClinicalTrials.gov