A randomized controlled clinical study to evaluate the efficacy of panchabhautika ghrita nasya over asta mangala ghritha nasya for cognitive enhancement in children with cerebral palsy.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- 1. To evaluate the efficacy of Panchabhautika ghrita nasya in the enhancement of cognitive functions in cerebral palsy.
研究概览
简要总结
BRIEF REVIEW OF INTENDED WORK:
INTRODUCTION:
Cerebral palsy (CP) is a nonprogressive neuromotor disorder that begins in childhood, often accompanied by disturbance of sensation, perception, cognition, communication, and behavior as well as making them physically, mentally handicapped, and socially apart.
The prevalence of the disease is ranging from 1-4/1000 live births with a male-to-female ratio of 1.4: 1, based on motor deficit, cerebral palsy is classified into spastic, hypotonic, dyskinetic and mixed cerebral palsy. Many cases of cerebral palsy are because of a combination of prenatal, perinatal, and post-natal factors.
Children with cerebral palsy exhibit symptoms like visual, hearing, speech, cognitive impairment, behavioral abnormality, drooling of saliva, feeding difficulties, communication difficulties, delay in reaching skill milestones, and lack in the attainment of higher mental functions which in turn leads to burden over the families and society.
Multisystem involvement in cerebral palsy makes its management symptomatic like speech therapy, occupational therapy, physiotherapy, medication, and surgery but still recovery is obscure and there is no availability of definitive treatment. Hence the parents of cerebral palsy children seek the support of another system of medicine like Ayurveda with a ray of hope.
In Ayurvedic literature analogs disease of cerebral palsy is not exactly mentioned but based on clinical features of the disease, it can be understood as a vata pradhan kaphanubandha vyadhi, which is manifested in various forms like sarvangavata, pakshaghata, ekangavata, pangu, khanja, kampavata, jadatwa, mukatwa due to siromarmabhighata. Etiologically it can be compared to shiromarmabhighata vata pradhan tridoshaja yapya vyadhi.
NEED FOR THE STUDY:
There is a need for study on the topic of cognitive enhancement in cerebral palsy because cognitive impairment is one of the biggest challenges for cerebral palsy survivors. Population registry data indicates that one in two children with CP has a cognitive impairment which elevates the risk for shortened life expectancy, comorbidities, and unemployment.
About 30 to 50 % of children with cerebral palsy have some level of cognitive impairment. Children with severe cerebral palsy have a greater likelihood of having cognitive impairments .
Cognitive impairment can affect various domains such as attention, memory, language, perception, and executive functions, which are essential for learning, communication, and daily functioning. Cognitive impairment can also have negative impacts on the quality of life, mental health, and social integration of individuals with CP.
In Ayurvedic classics, there are many treatments mentioned in vatavyadhi like snehapana, swedana, abhyanga, mrudu samshodana, basti, nasya, parisheka, rasayana chikista.
Few researches were been done motor development but not on cognition alone. As nasya is one of the effective procedure among the above treatments since it is best treatment in shiroadhistana gata rogas hence the nasya has been taken for proving its cognitive enhancing effect in children with cerebral palsy.
Among various drugs mentioned, Panchabhautika ghrita is selected as a trial drug to prove its efficacy in enhancement of cognitive functions in cerebral palsy, as it is mentioned as panchendriya vivardhana and which will be compared with Asta Mangala ghritha.
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
- 1.00 Year(s) 至 2.00 Year(s)(—)
- 性别
- All
入选标准
- •Children with all types of cerebral palsy are aged between 1-2 years irrespective of gender, religion, or socio-economic status, children associated with cognitive impairment will be included.
排除标准
- •Cerebral palsy with severe form seizures, and intellectual disability will be excluded.
- •Cerebral palsy associated with other systemic illnesses, metabolic disorders, congenital malformations, and congenital myopathies will be excluded.
结局指标
主要结局
1. To evaluate the efficacy of Panchabhautika ghrita nasya in the enhancement of cognitive functions in cerebral palsy.
时间窗: Clinical assessment will be done on both subjective and objective parameters at days 1 and 30 and follow-up at the 60th and 90th days.
2. To evaluate the efficacy of Astamangala ghritha nasya in the enhancement of cognitive
时间窗: Clinical assessment will be done on both subjective and objective parameters at days 1 and 30 and follow-up at the 60th and 90th days.
functions in cerebral palsy.
时间窗: Clinical assessment will be done on both subjective and objective parameters at days 1 and 30 and follow-up at the 60th and 90th days.
3. To evaluate the comparative efficacy of Panchabhautika ghritha nasya over the
时间窗: Clinical assessment will be done on both subjective and objective parameters at days 1 and 30 and follow-up at the 60th and 90th days.
Astamangala ghritha nasya in the enhancement of cognitive functions in cerebral palsy
时间窗: Clinical assessment will be done on both subjective and objective parameters at days 1 and 30 and follow-up at the 60th and 90th days.
次要结局
- Milestones development leading to the achievement of functional and financial independence thereby burden on the families and society will be decreased and further which will enhance motor development too.(Clinical assessment will be done on both subjective and objective parameters at days 1 and 30 and follow-up at the 60th and 90th days.)
研究者
Dr Radhika Injamuri
Sri Sri college of Ayurveda and Research Hospital, Cuttack, Odisha
