Preclinical and Clinical Study to Evaluate the Vranaropana Karma (Wound Healing Activity) of Sarala (Pinus roxburghii Sargent) Exudate
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The safety and clinical efficacy of the test drug by monitoring the wound area, wound appearance, TC, DC, ESR, Hb%
研究概览
简要总结
This clinical study, which will take place at the OPD of the IPGAER at SVSP Hospital, is a randomized, parallel-grouped control trial of a test drug comparing the safety and efficacy of Mupirocin for 28days in 20 patients suffering from different type of wounds. The primary outcome of this research is to evaluate the therapeutic efficacy of the test drug for its potential wound healing activity. The secondary outcome is to determine the safety of the test drug on quality of life among the patients suffering from different dermal injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The clinical study will be single blind clinical study, with two groups of patients (male and female both) suffering from acute wound, partial fistulectomy wound in the OPD and IPD of the hospital at IPGAER, Kolkata.
排除标准
- •Age below 20years or above 60years
- •Pre-existing diabetes mallitus
- •History of severe trauma
- •Pregnancy and lactating mother
- •Excessive P/R bleeding
- •Sexually transmitted disease
- •Malignancy
- •Patient with H/O multiple surgical intervention.
结局指标
主要结局
The safety and clinical efficacy of the test drug by monitoring the wound area, wound appearance, TC, DC, ESR, Hb%
时间窗: 28 days
次要结局
- Safe, Effective, Economical wound healing ayurvedic drug for the suffering patients(28 days)
研究者
Dr Amit Kumar Taraphdar
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital