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临床试验/CTRI/2024/11/076873
CTRI/2024/11/076873招募中不适用

Evaluation Of Mahapaisachika Ghrita Pratimarsha Nasya And Tungadhrumadi Taila Siropichu In The Management Of Adhd In Children – A Randomised Controlled Clinical Trial

KLE Shri B M Kankanawadi Ayurveda Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
There might be significant effect of Mahapaishachika ghrita pratimarsha nasya and

研究概览

简要总结

Attention Deficit Hyperactivity Disorder is one of the most common neurobiological disorders in children and adolescents. It has a negative impact on the children’s as well as the parents’ social lives and more often than not becomes a financial burden. The children in question end up with weak social relationships and low self-esteem and poor academic performance leading to an overall poor quality of life. The global prevalence of ADHD has risen to 7.6% of 96,907 children aged 3 to 12 years and 5.6% of teenagers aged 12 to 18 according to a study done in April 2023. The prevalence of ADHD in the city of Belagavi was studied to be 5.76% among children between 6 to 11 years of age. Isolated or combination of available pharmacotherapy is used with methylphenidate and dextroamphetamine, both of which are psychostimulants, as the mainstay treatment. One third of the patients who are being treated with psychostimulants report significant adverse results such as anorexia, abdominal pain, weight loss, depressed mood, sleep disturbances and lack of appetite. Concerns about long term effects and drug safety have led more than 50% of parents of ADHD children to seek Alternative/Complementary medicine. According to a meta-analysis, Ayurveda interventions have their benefits in reducing symptoms of ADHD. This Study is undertaken for the management of ADHD by the use of formulations expounded in Ayurveda treatises. ADHD is comparable to Unmada which is described as a disorder of the manovaha srotas. Ghrita is mentioned as a remedy for Unmada in Caraka Samhita Sutrasthana Annapanvidhi Adhyaya. It enhances cognitive abilities. Mahapaisachika ghrita, Tungadhrumadi taila and several other medicines are neuroprotective and cognitive enhancers which help in reducing the symptoms of ADHD.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
4.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Children of either sex between the age group of 4-16 years Children fulfilling the DSM V diagnostic criteria for diagnosis of ADHD.

排除标准

  • Children with any known acute or chronic, local or systemic infection Children with any known nose related pathology contraindicated for nasya Known case of cerebral palsy, mental retardation, epilepsy and hearing defect etc.
  • Children with congenital anomalies like cleft palate, CHD etc.
  • Children who have received any form of intervention for ADHD in the last 3 months.

结局指标

主要结局

There might be significant effect of Mahapaishachika ghrita pratimarsha nasya and

时间窗: 0 day | 7 days | 15 days | 30 days

Tungadhrumadi taila siropichu in the management of ADHD in children

时间窗: 0 day | 7 days | 15 days | 30 days

Measured by changes in the Vanderbilt ADHD assessment criteria

时间窗: 0 day | 7 days | 15 days | 30 days

次要结局

  • There might be significant effect of Mahapaishachika ghrita pratimarsha nasya and(Tungadhrumadi taila siropichu in the management of ADHD in children)

研究者

发起方
KLE Shri B M Kankanawadi Ayurveda Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Brihathi Bala V J

KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya

研究点 (1)

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