A DOUBLE BLIND RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE ANXIOLYTIC AND SEDATIVE EFFECT OF PARIJATA PUSHPA ARKA IN PRE OPERATIVE PATIENTS
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.Study to evaluate anxiolytic activity and sedative effect of parijata pushpa arka in patient posted for surgery.
研究概览
简要总结
This study is a doble blind randomized controlled clinical study to evaluate the anxiolytic and sedative effect of Parijata Pushpa Arka in pre operative patients. the patients will be randomly divided into two groups each group of 20 patients. total participants of 40. Group A recruited subjects will be administered with Parijata Pushpa Arka 10 ml and Group B recruited subjects will be administered with distilled water 10 ml. the study will be conducted at Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi, Karnataka. Al patients will be requested to complete the Amsterdam Pre operative Anxiety and Information Scale ( APAIS) and sedation level will be measured using Richmond Agitation Sedation Scale (RASS). Hence this study is an effort to evaluate the anxiolytic and sedative effect of Parijata Pushpa Arka as a pre operative medicine in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
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 aged between 18-60 years 2.Patients posted for elective surgery.
排除标准
- •1.Patient consuming antipsychiatry medicines 2.Patient consuming sedative or analgesic medicines.
结局指标
主要结局
1.Study to evaluate anxiolytic activity and sedative effect of parijata pushpa arka in patient posted for surgery.
时间窗: 7 days
2.To estimate the minimization of anesthetic drug and post operative analgesic
时间窗: 7 days
次要结局
未报告次要终点
研究者
Dr Bhagya Shaji
Sri Dharamasthala Manjunatheshwara College of Ayurveda , Hospital and Research Centre
