Assessment Of Efficacy Of Anti-tumorigenic Potential Of Desmostachya bipinnata(Db) Conjugated Silver and Platinum Nanoparticles In Therapeutic Management Of Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in Oral Mucositis Severity
研究概览
简要总结
We are conducting this study to develop an effective, plant-based nanomedicine for managing chemotherapy-induced oral mucositis, a painful and debilitating condition that significantly impacts cancer patients’ quality of life, nutrition, and treatment adherence. Current treatments provide limited relief and often have side effects, necessitating a safer, more effective alternative. The Db platinum mucoadhesive patch integrates Desmostachya bipinnata-derived phytochemicals with platinum nanoparticles, offering anti-inflammatory, wound-healing, and antimicrobial properties. This study aims to assess its efficacy in reducing mucositis severity, pain, and microbial load, while improving oral healing and patient comfort, ultimately enhancing clinical outcomes in cancer care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 30 years and above, diagnosed with oral squamous cell carcinoma (OSCC) and operated for the same.
- •Undergoing chemotherapy post-surgery and at risk of developing oral mucositis.
- •Willing to participate and provide informed consent.
- •No known allergies to the Db platinum mucoadhesive patch components.
排除标准
- •Patients with severe (Grade 4) oral mucositis at baseline.
- •History of severe allergic reactions to herbal or nanoparticle-based formulations.
- •Presence of active oral infections (bacterial, viral, or fungal).
- •Pregnant or lactating women or those with severe systemic illnesses.
结局指标
主要结局
Reduction in Oral Mucositis Severity
时间窗: The follow-up schedule includes assessments at Day 0 (baseline), Day 3 (early pain reduction and safety check), Day 7 (mucositis improvement and compliance check), Day 14 (final mucositis grading and microbial analysis), Day 21 (extended healing evaluation if needed), and Day 30 (long-term QoL assessment). These timepoints provide a comprehensive evaluation of the therapeutic efficacy, safety, and patient adherence to the Db platinum mucoadhesive patch
Measured using the World Health Organization (WHO) Oral Mucositis Grading Scale or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
时间窗: The follow-up schedule includes assessments at Day 0 (baseline), Day 3 (early pain reduction and safety check), Day 7 (mucositis improvement and compliance check), Day 14 (final mucositis grading and microbial analysis), Day 21 (extended healing evaluation if needed), and Day 30 (long-term QoL assessment). These timepoints provide a comprehensive evaluation of the therapeutic efficacy, safety, and patient adherence to the Db platinum mucoadhesive patch
Assessed by the reduction in ulcer size, severity of pain, and ability to eat/drink
时间窗: The follow-up schedule includes assessments at Day 0 (baseline), Day 3 (early pain reduction and safety check), Day 7 (mucositis improvement and compliance check), Day 14 (final mucositis grading and microbial analysis), Day 21 (extended healing evaluation if needed), and Day 30 (long-term QoL assessment). These timepoints provide a comprehensive evaluation of the therapeutic efficacy, safety, and patient adherence to the Db platinum mucoadhesive patch
次要结局
- Pain Reduction(Assessed using the Visual Analog Scale (VAS) (0 = no pain, 10 = worst pain).)