A controlled clinical study on the anti microbial activity of Sarshapa arka for wound asepsis in Dushta vrana.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Total microbial load difference – Pre and post application of Sarshapa arka and Povidone Iodine 5% solution.
研究概览
简要总结
This study is a open label controlled clinical trial to study anti-microbial activity of Sarshapa arka for wound asepsis in Dushta vrana. Subjects are allocated into study an control groups respectively.
Study group includes 15 subjects qualifying the inclusion criteria of the current study with topical application of Sarshapa arka for 7 days continuously and collecting pre and post application swabs of wound on day 1 to check the difference in total microbial load and on day 7 to observe the changes in wound.
Control group includes 15 subjects qualifying the inclusion criteria for the current study with topical application of Povidone idone 5% solution for 7 days continuously and collecting pre and post application swabs on day 1 to check the difference in total microbial load and on day 7 to observe the changes in wound.
Primary outcome measure - 1. Total microbial load difference – Pre and post application of Sarshapa arka and Povidone Iodine 5% solution.
Secondary outcome measure - 1. Improvement in the quality of life 2.To assess any change in the wound by visual observation.
Povidone iodine 5% solution is a commonly used anti-septic agent for preoperative procedures as it is considered as an ideal disinfectant. Although a vast amount of literature exists regarding its use as a topical anti-septic agent for wound asepsis in wounds, but only few works have been done regarding its reactions and long term usage. It has few disadvantages like using it for a long run has corrosive effects, local swelling, irritation, itching and rash. It has been also reported that usage of this solution didn’t increase or decrease the infection rate.
Aqueous distillate/Arka is relatively simple method of preparation and administration, with long shelf life and is safe to use topically as distillation process itself is sterile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects with lakshanas of Dushta vrana .
- •2.Subjects with chronic non- healing wounds , features such as wounds after 7 days , putipuya , daha , paka , kandu, shopha , dushta shonita srava.
- •3.Subjects with wound irrespective of stage of infection.
- •Subjects irrespective of age, gender , socioeconomic status will be selected .
- •Subjects who have willingly accepted to sign the consent form.
排除标准
- •Any topical application over Dushta vrana at the time of collection of swab.
- •Any systemic/topical antibiotic intervention for past 1 week.
- •3.Open wounds involving multiple body regions.
结局指标
主要结局
1. Total microbial load difference – Pre and post application of Sarshapa arka and Povidone Iodine 5% solution.
时间窗: 7 days
次要结局
- 1. Improvement in the quality of life(2.To assess any change in the wound by visual observation.)
研究者
Dr Nischintha H R
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and hospital, Bengaluru
