Clinical trial NCT06862817: Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Prevention of Pain and Progression of Radiation-induced Oral Mucositis
Official title: Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Radiation-induced Oral Mucositis (Randomized Clinical Trial)
Conditions: Radiation Indused Oral Mucositis
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.
Interventions:
description: 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
name: Aloe vera gel
type: Drug
description: . 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.
name: Benzydamine Hydrochloride 0.15% Oral gel
type: Drug
description: 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
name: bioadhesive gel
type: Drug
Study arms:
design_group_description: found that benzydamine mouth rinses and gels could prevent or reduce the severity of oral mucositis.
design_group_title: benzydamine hydrochloride mouth gel
design_group_type: Active Comparator
design_group_title: aloe vera gel
design_group_type: Active Comparator
design_group_description: . They incorporate biodegradable mucoadhesive polymers to enhance retention on active mucosal surfaces and regulate the release of the drug
design_group_title: bioadhesive gel
design_group_type: Placebo Comparator
Sponsor: Minia University
Collaborators: Faculty Of Medicine Minia University
Drug name mappings:
name: 芦荟提取物
lang: CN
name: Aloe vera extract
lang: EN
name: 盐酸苄达明
lang: CN
name: Benzydamine Hydrochloride
lang: EN