A randomized open label controlled clinical study to evaluate the efficacy of Dhattura Transdermal Patch in the management of pain due to sports injury with special reference to Ankle Sprain.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Marked decrease in pain in the affected ankle joint.
研究概览
简要总结
THIS STUDY HAS BEEN TAKEN UP TO EVALUATE THE EFFICACY OF DHATTURA TRANSDERMAL PATCH IN THE MANAGEMENT OF PAIN DUE SPORTS INJURY WITH SPECIAL REFERENCE TO ANKLE SPRAIN.
COMPARISION WITH MANJISHTADI LEPA
HYPOTHESIS
- NULL HYPOTHESIS:
H0:
THERE IS NO DIFFERENCE IN THE EFFICACY OF DHATTURA TRANSDERMAL PATCH AND MANJISHTADI LEPA IN THE MANAGEMENT OF PAIN DUE TO SPORTS INJURY WITH SPECIAL REFERENCE TO ANKLE SPRAIN.
- ALTERNATE HYPOTHESIS
H1:
EFFICACY OF MANJISHTADI LEPA IS BETTER THAN DHATTURA TRANSDERMAL PATCH IN THE MANAGEMENT OF PAIN DUE TO SPORTS INJURY WITH SPECIAL REFERENCE TO ANKLE SPRAIN.
H2:
EFFICACY OF DHATTURA TRANSDERMAL PATCH IS BETTER THAN MANJISHTADI LEPA IN THE MANAGEMENT OF PAIN DUE TO SPORTS INJURY WITH SPECIAL REFERENCE TO ANKLE SPRAIN.
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
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who fulfil the diagnostic criteria of ankle sprain such as history of an injury over the ankle associated with pain, swelling and restricted range of motion.
- •Subjects with grade 1 and grade 2 ankle sprain.
- •Subjects aged between 21-60 years , irrespective of gender, religion, occupation, economic status and educational status.
排除标准
- •Subjects with fracture and dislocation of ankle joint.
- •Subjects with grade 3 ankle sprain.
- •Subjects with previous history of ligament or bone reconstructive surgery to the ankle or foot.
- •Subjects presenting with wound over the ankle along with sprain.
结局指标
主要结局
Marked decrease in pain in the affected ankle joint.
时间窗: 1st, 3rd, 7th day
次要结局
- Reduced swelling and improved range of motion in the affected ankle joint.(7th and 14th day)
研究者
Dr Prithvi V
Sri Sri College of Ayurvedic Science And Research