A clinical study on cerebral palsy in children with Balapanchamrita Yoga and Procedure based therapy
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response in spasticity and range of motion (ROM) of joints.
研究概览
简要总结
Cerebral palsy is defined as a non-progressive neuromotor disorder of cerebral origin caused by insult or injury to developing brain during its early stage of development . Children affected with the disease present with developmental delay and motor deficits and may have one or more associated problem like mental retardation, seizures, feeding difficulties along with ophthalmologic and hearing impairments. Cerebral Palsy is most common motor disability affecting a large Pediatric population world-wide [2]. According to WHO(World Health Organization) estimation 10% of population has some form of disability due to different causes, in India it is 3.8% of population).Nearly 15-20% of total physical handicapped children are suffering from C.P. World- wide incidence of C.P is 2.5/1000 live births[4] and for India it is 3/1000 live births more than 15 million people worldwide and more than 25 lakh people in India are living with this disability.
For CP, there is no any direct reference in Ayurvedic classics.Some conditions are found discrete in classics at different,places like Phakka, Pangulya, Mukatva, Jadatva, Ekanga roga, Sarvanga roga, Pakshaghata, Pakshavadha etc. under the group of Vata Vyadhi which can be compared with the presentation of Cerebral palsy.If Vata is considered as major contributing factor for CP then Vata pacifying measures becomes essential component in the treatment. Treatment of Vata Dosha consists of a variety of treatment modalities like Abhyanga, Swedana and Basti.The total sample size for this clinical trial is required to be 30(15 in each group).The trial will be of 3 months~=Total 3 course of treatment, with an interval of 15
days between each course,One course of treatment will be for 17days [Udvaratana – 3 days Sarvanga Abhyanga and Bashpa swedana -14 days, Matra basti -7days(8thday of Sarvanga Abhyanga and Bashpa Swedana) and oral medicine with Balapanchamrita Yoga]. Group A (Abhayanga and Matra Basti with Ksheerabala Taila and Bashpa Swedana with Eranda Patra Kwatha with Internal Medication Balapanchamrita Yoga) and Group B (Abhyanga and Matra Basti with Murcchita
Tila Taila and Bashpa Swedana with simple water steam with Internal Medication Balapanchamrita Yoga)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group of 1 to 12 years of either gender Diagnosed Case of Cerebral palsy Parents submitting written consent to participate in the study.
排除标准
- •Progressive neurological disorder,Children suffering from any systemic illness,Children with severe intractable epilepsy as co-morbidity,Acute illness that would interfere with carrying out the interventions, Recent orthopedic surgery/casting/splint,Children had received botox (last 1yr) or had undergone phenol block injection or intrathecal baclofen medication,Fixed contractures, Congenital disorders like Down’s syndrome, Fragile -X syndrome or any congenital anomalies,Caregiver not willing to sign the informed consent form.
结局指标
主要结局
Response in spasticity and range of motion (ROM) of joints.
时间窗: assessment will be made on before treatment and after treatment | [After 02 months of Follow up]
Expected outcome will be 17.5%.
时间窗: assessment will be made on before treatment and after treatment | [After 02 months of Follow up]
次要结局
- Response in the quality of life (QOL)(90 days)