Randomized controlled clinical trial to evaluate the efficacy of Siddhartaka ghrita nasya in children with attention deficit hyperactivity disorder
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Attention Deficit Hyperactivity Disorder ADHD is a neurodevelopmental disorder commonly seen in childhood and adolescence, characterized by inattention, hyperactivity, and impulsivity. These symptoms significantly affect academic performance, social behavior, and emotional development. The global prevalence of ADHD among school going children is estimated to be around 7.1 percent. Modern pharmacological treatments provide symptomatic relief but are associated with side effects such as appetite suppression, sleep disturbances, irritability, and growth related concerns. Therefore, there is a need for safe and effective alternative therapies.
Gap identified, Rising burden of ADHD in children. Limitations and side effects of modern pharmacological treatment. Need for safe, sustainable, and holistic alternatives. Limited clinical evidence on Nasya therapy in ADHD.
In Ayurveda, mental health is defined as the state of equilibrium of Dosha, Agni, Dhatu, and Mala along with a pleasant state of Atma, Indriya, and Mana. ADHD can be correlated with Manasika Vikara, particularly Unmada, which involves disturbances in Mana, Buddhi, Smriti, and behavior. Nasya Karma is described as an important Panchakarma procedure for diseases of Shirah, as the nose is considered the gateway to the brain. Siddhartaka Ghrita, mentioned in Charaka Samhita, is a Medhya, Vata Kapha Shamaka, and Shirovirechaka formulation that may help in improving cognitive and behavioral functions.
The present study is planned as a randomized controlled clinical trial to evaluate the efficacy of Siddhartaka Ghrita Nasya in children aged 6 to 12 years diagnosed with ADHD. The trial group will receive Siddhartaka Ghrita Nasya, while the control group will receive Ashtamangal Ghrita Nasya. Assessment will be done at baseline, 30th, 60th, and 90th day using Vanderbilt ADHD Parent Rating Scale and SNAP IV scale.
This study aims to generate clinical evidence regarding the role of Siddhartaka Ghrita Nasya in reducing ADHD symptoms and improving attention, behavior, and cognitive functions in children.
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
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children who fulfill the Diagnostic criteria of DSM 5 for Attention Deficit Hyperactivity Disorder.
- •Children aged between 6 to 12 years at the time of recruitment.
- •Participants will be selected irrespective of gender, religion, or socioeconomic background.
排除标准
- •Children suffering from genetic syndromes or chromosomal abnormalities.
- •Nasya anarha.
- •Cases with schizophrenia, psychotic disorders, or significant neurodevelopmental comorbidities.
- •Children with significant sensory impairments, such as hearing or visual disabilities, that may interfere with assessment.
- •Children who are younger than 6 years or older than 12 years at the time of screening.
研究者
Dr Prasad Rajesh Bharambe
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya