Controlled Clinical Trial to assess the effectiveness of topical application of C1 herbal oil on superficial external wounds and split thickness skin graft donor sites for surgical wound healing
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Time to complete re-epithelisation
研究概览
简要总结
This study is a controlled, open label two phase clinical trial. Patients of age group between 18 and 60 years of either gender who present with superficial external wounds or raw areas requiring split thickness skin graft (STSG) coverage of at least 2 strips will be enrolled in the study. The study is being conducted at Jai Prakash Narayan Apex Trauma Centre, New Delhi, India. In first phase of the trial, C1 herbal oil will be used on STSG donor sites to assess the healing properties of the oil. The main ingredient of C1 herbal oil is an ayurvedic folklore medicine used for wounds and skin diseases, recommended for wound cleansing and healing purposes in ayurvedic classics. The physicochemical standards for use of this drug have been developed by the CCRAS.This clinical trial of herbal dressings in split thickness skin graft (STSG) donor sites is directed to find and validate the wound healing properties of herbal medicines, as claimed conventionally. if validated, it would go a long way in decreasing healthcare costs besides including herbal medicines in mainstream clinical medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with wounds requiring STSG cover.
排除标准
- •Known allergy/hypersensitivity to any of the components of the dressing
- •Fracture/DVT of lower extremity
- •A skin disorder that is chronic or currently active
- •Polytrauma patients
- •Wound at the surgical site prior to surgery
- •Neurological deficit at wound site (Hemiplegia etc.)
- •Haemoglobin level < 7.0 g/dl
- •Serum Albumin <3 g/dl
- •Subjects who, in the opinion of investigator, may not complete the study for any reason
- •Hepatic failure, renal failure, coagulopathy, known cases of Diabetes mellitus
- •Immunocompromised patients such as with Acquired immunodeficiency syndrome or receiving systemic immune suppression
- •Patients who have psychiatric disorders or physical disabilities that hinders the study
- •Pregnancy or Lactation
- •Patient has history of poor wound healing, history of smoking/drug/alcohol abuse
- •Poor prognosis patients unlikely to survive the trial period
- •Patients where a reference wound cannot be treated in isolation from other wounds.
结局指标
主要结局
1. Time to complete re-epithelisation
时间窗: 4 weeks
2. Incidence of Wound infection
时间窗: 4 weeks
3. Incidence of Adverse Reactions including allergic contact dermatitis
时间窗: 4 weeks
次要结局
- 1. Dressing Adherence Score(2. Pain during dressing changes)