Development of three-pronged strategy for burn wound management using plant extracts and enzymes
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparative difference in time required (in days) for complete healing of burn wound
研究概览
简要总结
It is an open label, active controlled, comparative, interventional, prospective clinical study to evaluate efficacy and safety of topical herbal creams and classical ayurvedic ghrita in burn wound. The study will be carried out at 1 to 2 centers in India. 1 mm thick quantity of medicine will be used for wet dressing alternate day till complete healing of burn wound. Primary objective of the study will be to assess comparative difference in time required (in days) for complete healing of burn wound. Secondary objectives of the study will be to assess comparative evaluation of wound healing process by comparing the mean surface area (percentage healing) of burn wound, comparative assessment of wound discharge, smell, color of burn area, pain during dressing, burning pain at rest, edema, granulation tissue, itching and pigmentation, global assessment for overall change by investigator and subjects and assessment of adverse events on baseline visit, every alternate day visit till complete healing of burn wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with burn wound of any etiology
- •Patient with 5 to 10 percent of burned surface area
- •Patients with second degree burns.
- •Subjects willing to sign informed consent and to undergo all the study procedure.
排除标准
- •Known allergy or hypersensitivity reaction to epidermal growth factor, silver sulfadiazine or other substances in formulation.
- •Burn wound involving the eyes, ears, nose, mouth & genitals
- •Pregnancy or breastfeeding
- •No underlying diseases that interfere wound healing such as known chronic kidney disease, liver disease, immunocompromised conditions.
- •Treatment with another investigational drug or other intervention (within a specified time frame)
- •History of drug or alcohol abuse
- •Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with patient’s participation in, and completion of the study.
结局指标
主要结局
Comparative difference in time required (in days) for complete healing of burn wound
时间窗: Baseline visit, every alternate day visit till complete healing of burn wound
次要结局
- 1. Comparative evaluation of wound healing process by comparing the mean surface area (percentage healing) of burn wound(2. Comparative assessment of wound discharge, smell, color of burn area, pain during dressing, burning pain at rest, edema, granulation tissue, itching and pigmentation)
研究者
Dr Suhas Abhyankar
Masina Hospital, Masina Hospital Trust