A Randomized Controlled Clinical Trial to study the effect of Raladi Lepa in Dadru Kushta with special reference to Tinea Corporis in children of age 5-16 years.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Reduction in signs and symptom of dadru kushta after application of Raladi lepa.
研究概览
简要总结
Dadru is a skin illness having high prevalence in children of age group 5 -16 years. there is need to find an alternative for local application as topical steroids commonly used are expensive as well as they have adverse effects.Raladi lepa seems to be promising as it has kandughna ( anti-itching) and kushatghna properties. The cardinal feature of dadru kushta is itching so the use of raladi lepa can be considered as an option. If research is conducted to evaluate the effect of raladi lepa in dadru kushta it will be definitely beneficial.
It will help us to expand our understanding of ancient remedies and their application in modern time. Valuable insight into the potential benefits of Raladi lepa in skin condition such as Dadru can be provided. Patients of age group 5-16 fulfilling clinical diagnostic criteria of Tinea corporis will be selected irrespective of their sex and socioeconomic status .Written consent from parents will be obtained for the study. Sample size using Daniel 1999 formula is 36. These patients will be selected by simple randomisation by lottery method. Total 72 patients selected will be divided into two groups named as group A (trial group) and Group B (control group), raladi lepa for Group A (trial group) and edagajadi lepafor Group B (control group) . Trial and control group will purchased form GMC certified pharmacy. Both drugs will be administered in Lepa form for 21 days . All SOP of lepa vidhi will be strictly followed during and after treatment. Observation will be done on day 0 , day 7 , day 14 and day 21. Result of the study will drawn on basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observation and result obtained during the treatment . Summery will be done and whole thesis work will be summarized. Conclusion will be drawn strictly on the basis of statistical analysis and will be unbiased.
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 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient fulfilling the diagnostic criteria with classical sign and symptom of dadru kushta like kandu, mandal and raaga.parents willing to participate of their child and ready to give consent . children between the age group of
- •16 years. Patient will be selected irrespective of sex, religion, socioeconomic status.
排除标准
- •Infected / pus discharging lesion.
- •Patient suffering from chronic or systemic illness.
结局指标
主要结局
Reduction in signs and symptom of dadru kushta after application of Raladi lepa.
时间窗: 14 days
次要结局
- Where the trial group stands in comparison with control group.(18 months.)
研究者
DR Sachin Prakash Gwalani
SMBT Ayurved College and Hospital