An open non randomized single Arm single centric clinical Trial to evaluate the Effectiveness of Inji Chooranam(Internal) and Vathakesari thylam(external) in the management of Balavatham in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of Siddha regimen Inji chooranam (Internal) and Vathakesari Thylam (External) is measured by Modified aswarth scale for the management of Balavatham in children.
研究概览
简要总结
INTRODUCTION:
This is an open non -randomized single arm single centric clinical trial to evaluate the effectiveness of INJII CHOORANAM (Internal) and Vathakesari thylam(external) for the management of Balavatham in children.In the pediatric text book of Mathalai noi thokuthi part 3,the symptoms of Balavatham is explained as inability /difficulty to use the limb,loss of power and tone,nerve weakness,inability to move the affected limb,deviation,loss of energy,weakness,chills,spasticity of the affected part.The drugs chosen for the project included INJI CHOORANAM as internal medicine,VATHAKESARI THYLAM as external medicine for thokkanam all of which have been used in the siddha system of medicine for many centuries either singly or in various combination.In order to limit this issue,efforts were undertaken to study the result of the use of a combination of these therapy.
METHODOLOGY:
This open clinical trial will be conducted in Ayodhidoss pandithar hospital.The sample size is 30 patients of both sex within age limit of 3-12 years and they will be selected based on inclusion and exclusion criteria.
RESULTS:
Effectiveness of the trial drug will be assessed by measuring the reduction of clinical symptoms using modified ashwarth scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children of age group 3-12 years
- •Weakness of one or more limbs
- •Loss of power and tone in muscles of the affected limb
- •Difficulty/ Inability in using the affected limb against gravity and resistance
- •Difficulty in using the affected limb.
排除标准
- •1.H/O Epilepsy 2.H/O Severe Aggressiveness with ADHD 3.H/O Autism 4.H/O Cerebral palsy 5.H/O Congenital Heart Disease 6.H/O Any other serious illness.
结局指标
主要结局
To evaluate the effectiveness of Siddha regimen Inji chooranam (Internal) and Vathakesari Thylam (External) is measured by Modified aswarth scale for the management of Balavatham in children.
时间窗: 7 days once
次要结局
- 1. To standardize the physicochemical properties of the trial drugs as per PLIM guidelines.(2. Reduction in the recurrence of clinical symptoms)