跳至主要内容
临床试验/CTRI/2023/07/054857
CTRI/2023/07/054857尚未招募2 期

Randomised Controlled Clinical Study to Evaluate the Efficacy of Abheerumuladi Ghrita in Children with Attention Deficit Hyperactivity Disorder

Dr BALASREE R JEEVAN1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Assessment of Attention Deficit Hyperactivity Disorder based on 33 items in ADHD T2 scale. Namely two sub scales -

研究概览

简要总结

Child development refers to the sequence of physical, cognitive, emotional and social changes that occurs  from birth till the conclusion of adolescence.Cognitive skills allow children to understand the relationships between ideas, to grasp the process of cause and effect and to improve their analytical skills. Neurodevelopment is a part of cognitive development and neurodevelopmental dysfunctions reflect disruptions of neuroanatomic structure or psychophysiologic functions and may be associated with academic under achievement, behavioural difficulties and problems with social adjustment. Attention Deficit Hyperactivity Disorder (ADHD) is one of the common neurobehavioural disorder and  one of the most prevalent chronic health conditions affecting school aged children. It is mainly characterised by inattention, hyperactivity and impulsivity among children, adolescents and even in adults.  The prevalence of ADHD among children and adolescents in India (2009-2019) ranges from  7.6%–15%. The prevalence is more in male children (9.40%) than female children(5.20%). The peak prevalence in males is observed in the age group of 8-15 years and in females from 7.6 – 15 years. Children with ADHD have poor social interactions, thus they have poor relationships with parents, siblings and teachers. They are also poor in academics, thus, resulting in poor self esteem, peer rejection, inability to evaluate self and have negative emotions. The abnormal behaviour of the child is a major cause of concern for the parents as it affects their social status. This may eventually lead to psychological stress in parents and has serious implication on the quality of life of the family members.  Children with behavioural disorders are incredibly vulnerable to rejection and anger and they deserve to grow up in a safe environment, with warm acceptance from the society. Thus, interventions are required to tackle down this serious social burden. Currently psychosocial and behavioural therapies are widely adopted in the management of ADHD and to control the symptoms of ADHD psychostimulant drugs are being used rarely. The psychostimulant drugs used, increase the release and inhibit the reuptake of dopamine, thus enhancing attention span, concentration, and reducing impulsivity. They have no role in enhancing the academic performance of the child, but have severe adverse effects like sleep disturbances, irritability, growth suppression, adverse cardiovascular events like sudden cardiac death, and myocardial infarction.   ADHD can be considered under ‘Unmada’ spectrum of disorders in Ayurveda. The features like Cheshta Vibhrama(unsteadiness in activities), Ä€chara Vibhrama (perversion of conducts), Smriti Vibhrama (perversion of memory) and Bhakti Vibhrama (perversion of interest) of Unmada are predominantly observed in ADHD.   Ayurveda aims at correcting these Vibhramas by correcting the functions of Buddhi and Manas through various measures. One such time tested measure is administration of “Medhya Yogasâ€, which sharpens the cognitive skills of the child. Though several Medhya Yogas are mentioned in Ayurveda, only a handful of them have been evaluated in the treatment of ADHD, a disease which has multiple deficits.   Abheerumuladi Ghrita is one such formulation mentioned in Unmada Chikitsa which aims at correcting the Chestadi Vibhramas through its Medhya properties.   Hence, the Present study is an effort to evaluate the efficacy of Abheerumuladi Ghritha in children with Attention Deficit Hyperactivity Disorder.

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
7.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Children in the age group of 7-12 years, irrespective of their gender, religion and socio- economic status.
  • 2.Children fulfilling the diagnostic criteria of ADHD as per DSM
  • 3.Children whose parents are willing to sign the written consent form and follow the treatment protocol will be included.

排除标准

  • 1.Children below 7 years and above 12 years of age will be excluded.
  • 2.Children with other neurodevelopmental disorders and psychotic disorders like childhood Epilepsy, Mental Retardation, Pervasive Developmental Disorder not other-wise specified, Depression and Anxiety disorders, Rett’s syndrome, Conduct Disorder, Schizophrenia etc will be excluded.
  • 3.Children with other systemic diseases will be excluded.

结局指标

主要结局

Assessment of Attention Deficit Hyperactivity Disorder based on 33 items in ADHD T2 scale. Namely two sub scales -

时间窗: Before intervention - 0th day | After intervention - 60th day, 90th day

1. Inattention

时间窗: Before intervention - 0th day | After intervention - 60th day, 90th day

2. Hyperactivity/ Impulsivity

时间窗: Before intervention - 0th day | After intervention - 60th day, 90th day

次要结局

  • Assessment of Attention Deficit Hyperactivity Disorder by assessing Lakshanas of vibhramas mentioned in unmada like(1. chesta vibhrama)

研究者

发起方
Dr BALASREE R JEEVAN
申办方类型
Other [self]

研究点 (1)

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