Formulation, Characterization and In-vivo Evaluation of Controlled Release Intranasal Films of Vitamin D3 as an Optimistic Dosage Form for Rapid and Effective Healing of Cauterized Turbinectomy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Healing of cauterized tissues after surgery procedures
研究概览
简要总结
One of this method's drawbacks is the healing of cauterized cartilage after processing. It was reported that the healing is so slow as no dosage form can reach this place in addition to the scares produced from healing is very irritable to the patient.
From this point, the investigators start searching for a solution to this problem and reach the repositioning of Vitamin D3 (calciferol) as an active ingredient for the rapidity and efficacy of burn healing.
The dosage form of choice that was reported before for intranasal application by the same team of investigators and gave good results. the intranasal films were proved for its convince, simplicity, efficacy, and compliance to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients complain of nasal obstruction
- •do not respond to medications
- •treatment need surgery
- •patients accept following up in a timely manner for 3 weeks
排除标准
- •no nasal polyps,
- •have problems with the surgical procedures
- •have allergy with any of the treatment components (vitamin D3 or chitosan)
- •don't follow instructions or miss the following up
研究组 & 干预措施
vitamin D film
Prepared intranasal films containing vitamin D3 by the investigators and administered to the right nostril with the aid of an ENT surgeon
干预措施: Vitamin D3 (Drug)
control group
No devices will be added
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Healing of cauterized tissues after surgery procedures
时间窗: three week
The outcome will be measured by endoscopic scanning pre and after application of the drug in the dosage form (representing the percent of healing) by the ENT surgeon.
次要结局
- Assessment of grades of healing by ENT surgeon(three weeks)
- patients compliance from the new dosage form(three weeks)
研究者
Soad Ali
lecturer of pharmaceutics and clinical pharmacy Deraya university
Deraya University