A Clinical Study on Mahamasha Taila Matra Basti with Shashtika Shali Pinda Sweda and Ksheerabala Taila Orally in the Management of Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The research drug is expected to be beneficial for improving symptoms of cerebral palsy like muscle spasm, increase tendon extensibility, pain relief, inflammation, swelling and other symptoms of aggravated Vata Dosha, reduction in muscle spasticity and facilitate free movement of joint preventing from deformities and contractures.
研究概览
简要总结
In this research we evaluate the efficacy of Mahamasha taila matra basti with Shashtik shali pinda sweda and Ksheerabala Taila orally in Cerebral palsy. This is a randomized parallel group trial Maximum 30 subjects will be taken aged between 1 to 10 years, in first group Mahamasha taila matra basti will be administered second group -Mahamash taila matra Basti and Ksheerbala Avartana taila orally will be administered in group Prior to Mahamash taila matra basti , Abhyanga with “Mahamasha Taila†and Shastik shali pinda sweda, will be done in each group. Dose of Mahamash taila matra Basti will be decided on basis of classical reference as mentioned in Charak siddhi 4/53 and Kashyap samhita, minimum dose is one pala about 50 ml but according to bala kala desh agni tolerance capacity of the children the dose will be fixed for each patient, therefore according to per kg weight dose is approx. 1 ml/ kg body weight
Dose of Ksheerabala taila will be decided as per CCRAS 2005 guidelines
For children of 1-5 age group: 5-15 drops per day
For children of 6-15 age group: 2-5 gms per day
DURATION OF TRIAL:-
It will be a trial of 90 days (approximate 3 month)
•3 Schedules of Matra basti will be adopted i.e. 15 days Schedule.
•Matra basti of Mahamash Taila.
•One complete Schedule of Matra basti will be followed by gap of 15 days in both groups.
•Oral administration of Ksheerabala oil will be continued for 90 days without any gap only in group B.
FOLLOW UP – The clinical assessment of patients will be carried out during the trial, 1st on 15th day(after 1st schedule of matra basti) , 2nd on 30th day(after 15 days gap of 1st matra basti schedule), 3rd on 45th day(after 2nd Matra basti schedule) & 4th on 60th day(after 15 days gap of 2nd Matra basti schedule) .5th on 75th day(after 3rd Matra basti schedule). 6th on 90th day( after 15 days gap of 3rd Matra basti schedule)
•After the completion of trial, patients will be called for follow up after 1 month.
According to World Health Organization (WHO) estimation, 10% of the global population has some form of disability due to different causes; in India, it is 3.8% of the population.
For India, the estimated incidence is around 3/1000 live births; however, being a developing country, the expected actual figure may be much higher.
The few available treatments in modern medicine system to reduce generalized spasticity and another complications of cerebral palsy are associated with a high incidence of adverse effects and complications. There is an urgent need for studies to establish the efficacy of the Ayurvedic therapies and to find additional safe and effective treatments to help children affected by generalized spasticity due to CP. None of the oral medications used to treat spasticity in children has been adequately tested for safety and efficacy. There are minimal or no data regarding the pharmacokinetics or appropriate dosing parameters to treat children. These critical questions deserve serious research efforts. Currently there is no cure for CP. Answers can be found in Ayurvedic system of medicine. Ayurveda has been in use since time immemorial and is time tested. The present study was conducted with a goal to improve physical activity, capacity of mobility, social participation, and health-related quality of life in children with CP by means of Ayurvedic intervention using a combination of massage therapy, fomentation, and Ayurvedic drug administration through enema and oral route, i.e. Mahamasha taila matra basti and ksheerabala taila orally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children physically and mentally handicapped due to cerebral palsy.
- •2.Children with delayed growth and milestone development.
- •3.Already diagnosed cases of CP.
排除标准
- •1.Children below 1years and above 10 years of age.
- •2.Children of CP with major congenital disorder & other disease status viz.
- •Juvenile DM, Acute infections etc.
- •3.Children with any progressive neurologic anomalies.
- •4.Child suffering from any Muscular dystrophy.
- •5.Children with severe systemic illness.
结局指标
主要结局
The research drug is expected to be beneficial for improving symptoms of cerebral palsy like muscle spasm, increase tendon extensibility, pain relief, inflammation, swelling and other symptoms of aggravated Vata Dosha, reduction in muscle spasticity and facilitate free movement of joint preventing from deformities and contractures.
时间窗: Three months
次要结局
- 1.Matra Basti shows good result in CP patients, especially by improving growth (height, weight, chest circumference) and development (head holding and sitting)(2.Ksheerabala oil is rejuvenating, which helps to repair the damaged tissue. It also provides nourishment to the nerves, brain, and spinal structures. The main ingredient of Ksheerabala Oil is Bala (Sida Cordifolia), which is a potent neuroprotective herb)