CTRI/2019/06/019914已完成1 期
A randomised clinical trial of Karnapichu with Gandhaka Taila, Karnadhupana and Rasnadi Guggulu in the managemaent of Karnasrava w.s.r. to chronic suppurative otitis media (C.S.O.M.)
National Institute Of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Karnapichu with Gandhaka Taila,Karnadhupana and Rasnadi Guggulu in the management of Karnasrava(C.S.O.M.)
研究概览
简要总结
The study will be a randomised clinical phase1 trial.Thescreened patients will be randomly divided in two groups using computerizedrandomization method for unbiased allocation.
Group A:Patients will be treated withKarnapichu with GandhakaTailaalong with RasnadiGugglu.
Group B:Patientswill be treated withKarnadhupana alongwith Rasnadi Guggulu.
Aimsand objectives:
- To study Karnasrava in bothAyurveda and modern parlance.
- To evaluate the efficacy of Karnapichu and Karnadhupana on Karnasrava clinically.
- To evaluate the effect of Rasnadi Guggulu on Karnasravaclinically.
- To compare the efficacy of trial drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 8.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with signs and symptoms of karnasrava described as per Ayurvedic and modern parlance.
排除标准
- •Age below 8 years and above 60 years.
- •Systemic diseases like uncontrolled DM, Meningitis,Tuberculosis,HTN etc
- •History of long term intake of ototoxic drugs
- •C.S.O.M. with complications like acute mastoiditis, petrositis, facial paralysis, adenoids, tonsilitis, labyrithitis etc.
- •Pregnant women.
结局指标
主要结局
To evaluate the efficacy of Karnapichu with Gandhaka Taila,Karnadhupana and Rasnadi Guggulu in the management of Karnasrava(C.S.O.M.)
时间窗: 2 months
次要结局
- Any adverse event reported voluntarily, observed or enquired.Recurrence in sign and symptoms of Karnasrava(C.S.O.M.)(2 Months)
研究者
研究点 (1)
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