Comparative Evaluation of Efficacy of Modified form of Sindooradhya Taila (Ointment) vs Vachadi Ointment the management of Scabies (Pama) in school-going children:A Randomized clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Sindooradhya ointment in Pama (Scabies) in Children of 5 year to 16 years by gradation scale parameter with number and size of patches
研究概览
简要总结
the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized standard Control Superiority Clinical Trial. it will include a 14 days treatment period and after 14 days follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 willing to give written informed consent with either gender having age of 05 to 16 years and patients Parents willing to allow their child to participate with Clinically diagnosed Pama (Scabies).
排除标准
- •Patients who have had a long-term Pama Kushtha infection and with additional skin conditions and Having serious systemic illnesses such as HIV TB systemic lupus erythematosus.
结局指标
主要结局
To evaluate the efficacy of Sindooradhya ointment in Pama (Scabies) in Children of 5 year to 16 years by gradation scale parameter with number and size of patches
时间窗: at 7th, 15th days
次要结局
- To evaluate the efficacy of Vachadi ointment in Pama (Scabies) in Children of 5 year to 16 years by gradation scale parameter with number and size of patches(at 1st , 2nd week)
研究者
Dr Tushar Subhash Nandanwar
Mahatma Gadhi Ayurved college Hospital and Research centre