An open label Clinical trial to evaluate clinical efficacy and safety of Ayush AGT for external wounds.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Primary Outcome Measures
研究概览
简要总结
This study is a An Open Label Clinical Trial to Evaluate Clinical Efficacy and Safety of AYUSH AGT cream for External Wounds. Sufficient quantity of AYUSH AGT cream will apply on open wound for four weeks. Study sample size will be 30 patients. It will be conducted in three centers in India. Primary Outcome Measures is to study time frame required time to complete re-epithelialization and to assess Percentage area of re-epithelialization on day 7, 14, 21and 28 via Bates-Jenson wound assessment tool. Secondary outcome measures to see the Incidence of wound infection while applying AYUSH AGT cream, Pain during dressing changes (score) any systemic effect after treatment CBC, blood glucose, electrolyte, hepatic and renal functions will be analyzed to find any changes, Incidence of Blisterin and to observe incidence Incidence of adverse reactions during treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
- •.1 Patients of either sex with age between 18 and 60 years 2 Patients with Superficial externalwounds requiring dressing
- •Solitary wound not less than 1 inches (2.5 cm) in diameter 4 Patienwilling to participate in the study for 1 month.
排除标准
- •1Known allergy/hypersensitivity to any of the components of the dressing 2.Wound associated with fracture 3.Wound associated with skin disorder that is chronic or currently active like psoriasis, eczema 4.Neurological deficit at wound site 5.Hemoglobin level <7.0 g/dl, serumalbumin <3 g/dl 6.Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S.Creatinine > 1.2 mg/dl) 7.Known cases of Diabetes Mellitus, AIDS & other sexually transmitted diseases, Malignancy or known history of coagulopathy 8.Patients receiving immune-suppressive medication 9.Pregnancy or lactation 10.Varicose veins/Deep Vein Thrombosis 11.Wounds requiring full thickness graft 12.Patients where a reference wound cannot be treated in isolation fromother wounds.
- •13.H/o hypersensitivity to any of thetrial drugs or their ingredients.
- •14.Patient taking participationin any other clinical trial 15.Any other condition which the Investigatorthinksmay jeopardize the study.
结局指标
主要结局
Primary Outcome Measures
时间窗: Primary Outcome Measures | Time to complete re-epithelialization (Time Frame: 4 weeks.)
Time to complete re-epithelialization (Time Frame: 4 weeks.)
时间窗: Primary Outcome Measures | Time to complete re-epithelialization (Time Frame: 4 weeks.)
次要结局
- 1.Incidence of wound infection (Time Frame: 4 weeks(2.Pain during dressing changes (score) [Time Frame: 2 weeks])