A NON RANDOMIZED CONTROL TRIAL ON THE EFFECTIVENESS OF SIROUTSADANA OVER SIROLEPA WITH BALASOHALADI IN HYPERACTIVITY ASSOCIATED WITH AUTISM SPECTRUM DISORDER IN CHILDREN AGED 3- 12 YEARS.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- DR ANUSRI PRADEEP
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- PRIMARY: Amount of Change in the hyperactivity domain of ASD with siroutsadanam as compared to sirolepam.
概览
简要总结
Autism spectrum disorder (ASD) is a neurodevelopmental condition with heterogeneous etiologies, which have in common clinically significant, persistent deficits in social communication, and restricted, repetitive patterns of behavior and or interest. Prevalence grown to one in 36 children effected with Autism. One of the most prevalent symptoms in children with ASD is hyperactivity. Children that exhibit hyperactivity are considered to be abnormally or exceptionally active. People who are hyperactive typically find it impossible to delay the experiences and desires they have. When a kid with ASD exhibits a combination of these symptoms, such as difficulty initiating or ending a conversation, interacting with peers, or joining them, it can be very challenging to manage their hyperactivity. Compared to other parent groups, parents of hyperactive ASD children report higher levels of stress. Atypical antipsychotics, behavioral therapy, and psychostimulants have all been used with some degree of success in the management of hyperactivity. However, the clinical response to the stimulants varies, and neither medication group is entirely satisfying. A significant gap in the current situation is the adverse effects and disadvantages of these medications, as well as the shortage of professionals qualified to provide intense therapy. According to Ayurveda Hyperactivity with ASD can be considered under Balaunmada and it impair all the three dosas specifically with vata- pitta predominance. It imparts impairment in Budhi, Sanja, Jnana, Smriti, Seela, Cheshta, Acharam. Thereby resulted in Avarana of Manovahasrotas. In order to evaluate the effect of Siroutsadana (rubbing of scalp with medicated paste) over Sirolepa (covering the scalp with medicated paste) present in ayurvedic textbooks using Balasohaladi yogam in Hyperactivity with ASD, A nonrandomized controlled trial with 16 participants each in study and control group of age group 3–12 years and patient satisfying DSM-5 criteria having CARS score above 30, ADHD T2 score above 60 recruited into the study. The samples will be selected following the inclusion criteria, from the OPD of Dept. of Kaumarabhritya, Govt. Ayurveda College Hospital for Women and Children, Poojappura. For both study group and control group, the total period of intervention is 28 days. The study group will be given Siroutsadana and sirolepam using Balasohaladi yogam for 48min (1muhurtham) and the control group will be given with Sirolepam with Balasohaladi yogam for 48Min (1muhurtam) for a period of 28 days. Assessment will be done with internationally accepted tools like ADHD T2, Childhood Autism Rating Scale [CARS] and Autism Treatment Evaluation checklist [ATEC] before and after the intervention and also after 14 days of follow up. Data will be finally analyzed using appropriate statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Subject of both sex of age group 3 to 12 years satisfying DSM 5 criteria for ASD and having a CARS score above 30 and ADHD T2 score above 60.
排除标准
- •Clinically diagnosed cases of PDD (Pervasive developmental disorder) like Rett syndrome, Asperger’s syndrome, Childhood Disintegrative disorder, PDD.
- •NOS (Pervasive developmental disorder- Not otherwise specified)
- •Clinically diagnosed cases of other developmental disorders and neurological disorders.
- •Children with recurrent respiratory tract infections, and intractable epilepsy. The exclusion is based on clinical features, history of illness along with available investigation report.
结局指标
主要结局
PRIMARY: Amount of Change in the hyperactivity domain of ASD with siroutsadanam as compared to sirolepam.
时间窗: Changes in the pre and post assessment scores of CARS, ATEC, ADHD T2 in Hyperactivity in children with Autism. | ASSESSMENT AFTER 4 WEEKS,8 WEEKS
次要结局
- To study the changes in the Behavioral & Social domain also the severity of Autism spectrum disorders (ASD).(Changes in the pre & post assessment scores of CARS, ATEC, ADHD T2 in Hyperactivity in children with Autism.)
研究者
DR ANUSRI PRADEEP
MD SCHOLAR