跳至主要内容
临床试验/CTRI/2024/06/068680
CTRI/2024/06/068680尚未招募2 期

A Single Arm Open Label Clinical Trial To Evaluate The Efficacy Of Combined Therapy - Brahmyadi Syrup With Shirodhara And Shiropichu In The Management Of Attention-Deficit/Hyperactivity Disorder

National institute of ayurveda jaipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024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
Change in the scoring/grading of symptom of ADHD on NICHQ Vanderbilt Assessment scale.

研究概览

简要总结

Modern ADHD treatment have significant drawback including the potential to have a serious negative influence on a child’s entire development. Ayurveda is holding numerous ways to diagnose and manage various diseases. Although several studies have been conducted and some remain are on-going on this disease but still any specific precise management and strategy not have been established, thus much more research must be done in order to achieve this goal in future. Due to their low socioeconomic level many parents in developing nations like India unable to afford the different therapies required for ADHD. Therefore, careful research is needed to discover more affordable, accessible and palatable medications for such disease. BrahmyadiYoga is mentioned in BhaisajyaRatnavali text book, Unmadrogaadhikaar Chapter Number 24 as a *Unmadaharayog.*Till now, as per scholars’ knowledge there is no research work available on this drug for ADHD in children. It contains drugs like Brahmi, Vacha, Shankhpushpi, Kushmaand, Kustha which are considered as Medhya (~nootropic) drugs according to Acharya Priyavart Sharma.Active ingredients of these drugs acts on brain function which may also be beneficial in improving the symptoms of ADHD. Also, these drugs are easily available and cost effective. To improve the palatability and compliance of drug, Brahmyadiyoga will be modified as a Syrup form. Bacosides active ingredients of Brahmi responsible for improving memory related disorders, and enhance efficiency of transmission of nerve impulse there by strengthening memory and cognition.Shankhpushpi has a calming effect by regulating the body’s production of the stress hormones, adrenaline and cortisol. The bioactive components of Convolvulus pluricaulis are Sitosterol glycoside, octacosanoltetracosane, hydroxycinnamic acid, and glucose. These metabolites contribute to its nootropic and memory enhancing properties, along with its other pharmacological activities. Rhizome of Vacha has been reported to possess tranquilizing, neuroprotective, anti-cholinesterase, anticonvulsant activity.Certain research works done on Kushmanda have yielded beneficial effects on mental health. Kushmanda considers best for promotion of longevity, promotion of memory and intellect Kustha have Hypotensive and vaso relaxation effect, CNS depressant effect, immune-modulator.

Shirodhara is a method whereby pouring any liquid or medicated liquid(milk/oil/buttermilk)  over the forehead of the patient in the form of a regular stream from a particular height (precisely 3.14 inches (as mentioned in Dharakalpa of Sahasrayogam) in the form of oscillatory movements for 30-45 minutes. Mind and higher consciousness is affected in disease like ADHD. And these can be considered under broad term Unmada in Ayurveda. For providing an tranquilizing effect and increasing attention, Shirodhara is the well-known treatment modality. Shiropichu is procedure of applying the oil to the vertex using cotton pad impregnated with oil. It is found to be more beneficial in neuropsychiatric disorders. Because of its easy applicability along with added effect of all Moordhinitaila these considred as important procedure in ADHD.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children of either sex in between age group of 5 to 10 years.
  • Diagnosed case of ADHD.
  • Children with average/normal IQ level (more than 90) Subjects satisfying DSM-5 criteria of diagnosis.

排除标准

  • Children with any known psychiatric illness and neurological disorder.
  • Children with gross brain damage causing mental retardation Children with any genetic disorder Children with gross physical disability Children with any associated long term or fatal disease.

结局指标

主要结局

Change in the scoring/grading of symptom of ADHD on NICHQ Vanderbilt Assessment scale.

时间窗: Every 2 week of clinical trial. | After 16 week of clinical trial completion.

次要结局

  • Change in the quality of life by improvement in cognition & concentration with safe & effective treatment.(Every 2 week of clinical trial.)

研究者

发起方
National institute of ayurveda jaipur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Suman rulaniya

NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN

研究点 (1)

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