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临床试验/CTRI/2025/03/082832
CTRI/2025/03/082832尚未招募2 期

Clinical efficacy of the combination of Guduchi Churna and Vatahara diet in Pediatric Cerebral Palsy -A Randomized Controlled Clinical Trial

Saurabh bagal1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年3月28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
20
试验地点
1
主要终点
To clinically assess the efficacy of combination of Guduchi Churna and Vatahara Diet in motor function in Cerebral Palsy

研究概览

简要总结

Cerebral Palsy (CP) is the most common cause of physical disability in children, affecting 2-2.5 per 1,000 live births globally, with a prevalence of 2.95 per 1,000 live births in India. CP is a group of non-progressive disorders that impair physical movement, with associated disturbances in sensation, perception, cognition, communication, behavior, and epilepsy. It is classified into four main types: Spastic (70%), Athetoid/Dyskinetic (15%), Ataxic (5%), and Mixed (10%).

Despite advancements in newborn care, the management of CP remains challenging. There is currently no cure for CP, as the brain damage causing motor dysfunction is irreversible. Treatment focuses on improving the quality of life and reducing symptoms through interdisciplinary approaches. These include physical therapy, occupational therapy, neurodevelopmental treatments, pharmacological interventions, and sometimes surgery. Techniques like Neurodevelopmental treatment-Bobath, Constraint-Induced therapy, electrical stimulation, and the use of orthoses are commonly employed. However, research on the efficacy of traditional treatments, including physiotherapy, has been inconclusive. There is also ongoing debate regarding the effectiveness of therapeutic exercises like passive stretching in children with spasticity, as evidence remains weak.

In Ayurveda, CP is not recognized as a specific disease but is viewed through the lens of Vata Vyadhi, a disorder of the Vata dosha. CP symptoms are believed to result from an imbalance in Vata, which can be pacified through therapies like Snehana, Swedana, and Basti. Ayurvedic treatments for CP emphasize using medications that promote digestion, stimulate growth, and cleanse the body’s microchannels. Diets that are Vata-alleviating and Brihmana (restorative) are recommended, such as those containing Masha (black gram), Yava (barley), and Godhuma (wheat), which are believed to provide nourishment, stability, and vitalizing effects.

The Medhya (intellect-promoting) action of ’Guduchi’ (Tinospora cordifolia) is also highlighted as a potentially beneficial treatment in CP. Guduchi is known for its cognitive-enhancing properties and may help in neurological recovery. Studies suggest that Guduchi improves memory and enhances learning, possibly making it useful for cognitive and motor development in children with CP. It also balances the Tridoshas (Kapha, Pitta, and Vata), which could help restore the neurological functions affected in CP.

Despite the potential of Guduchi and other Ayurvedic treatments, further clinical trials are needed to evaluate their efficacy in managing CP. Research on combining Guduchi with a ’Vataghan diet’ (Vata-alleviating diet) for treating pediatric CP is still lacking. The article concludes by stressing the need for more research on the integration of Ayurvedic and conventional treatments for better management of Cerebral Palsy.

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
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • subjects suffering from Cerebral Palsy in the age group – 2 TO 10 yrs.
  • All types of Cerebral Palsy will be included.

排除标准

  • Subjects suffering from grade 5 spasticity and contractures.
  • Subjects suffering from metabolic syndrome,
  • Suffering from developmental delays due to other syndromes like Down syndrome, Williams syndrome, West syndrome.
  • Children with severe infectious diseases such as TB, Meningitis, major congenital malformations such as congenital heart disease (CHD).

结局指标

主要结局

To clinically assess the efficacy of combination of Guduchi Churna and Vatahara Diet in motor function in Cerebral Palsy

时间窗: On Baseline, 30th day, 60th day, 90th day

次要结局

  • Improvement of both gross motor milestone and fine motor milestone while also aiming to achieve the developmental milestone(On Baseline, 30th day, 60th day, 90th day)

研究者

发起方
Saurabh bagal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Saurabh Subhash bagal

Bharati Vidyapeeth (Deemed to Be University) College of Ayurved and Hospital

研究点 (1)

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