A Randomized open-label clinical study on the efficacy of Vishwadi Guggulu with Ksheerbala 101 Avartana Taila Pratimarsha Nasya with special reference to Parkinsons disease and its comparison with the efficacy of Kapikacchu Choorna with Ksheerbala 101 Avartana Taila Pratimarsha Nasya.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in symptoms of Parkinson’ s Disease based on MDS-UPDRS Scale
研究概览
简要总结
Parkinson disease is a progressive neurodegenerative disorder that mainly affects elderly people and causes tremors rigidity slow movements and gait problems. It is the second most common neurodegenerative disease worldwide and its global burden has increased significantly over the past decades with further rise expected in the coming years. In India it represents a major proportion of neurodegenerative disorders. Current treatments such as Levodopa and dopamine agonists provide symptomatic relief but are associated with behavioral and non behavioral side effects.
In Ayurveda Parkinson disease closely resembles Kampavata a disorder related to Vata Dosha. Symptoms described in classical texts include tremors in hands and feet giddiness discomfort disturbed sleep and cognitive decline which greatly affect quality of life. Although Ayurveda offers potential therapies for Vata disorders there is limited modern clinical evidence supporting its role in managing Kampavata. Therefore scientific evaluation is needed.
Vishwadi Guggulu mentioned in classical texts is considered beneficial for managing tremors and is selected for evaluation in this study. Kapikacchu known for its nourishing and Vata balancing properties and as a natural source of L dopa is chosen as a comparative drug. In addition Pratimarsha Nasya using Ksheerabala 101 Avartana Taila is administered in both groups based on the Ayurvedic principle that the nose acts as a gateway to the brain helping to balance Vata in the central nervous system
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
- 40.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Subjects in the 40 to 70 age range regardless of gender 2.Subjects who exhibit two or more classical clinical symptoms of Kampavata like Karapada tale kampa, Deha bhrama , Dukha, Nidrabhanga , and Mati ksheena 3.Subjects presenting with two or more clinical features of Parkinsons Disease like tremors, bradykinesia ,rigidity, postural instability, sleep disturbances ,cognitive impairment 4.Subjects who have been freshly diagnosed with Idiopathic PD 5.Subjects willing to participate with written informed consent in the language they can understand.
排除标准
- •1.Subjects with other varieties of Tremors like essential tremors, senile tremors.
- •2.Subjects who are currently receiving any concurrent medication for Parkinsons disease.
- •3.Subjects diagnosed with uncontrolled metabolic disorders like Diabetes mellitus, Hypertension and Thyroid disorders.
- •4.Subjects with history of Traumatic Head Injury.
结局指标
主要结局
Changes in symptoms of Parkinson’ s Disease based on MDS-UPDRS Scale
时间窗: Group A-Vishwadi guggulu with Ksheerabala 101 Avartana talia pratimarsha nasya (Trail group ) | Group B- Kapikacchu choorna with Ksheerabala 101 Avartana talia pratimarsha nasya (Comparitive group) | Trail period-30 days | Assesment will be done on 0th day baseline day ,31st day and 45th day.
次要结局
- 1. Generation of in- depth analyzed data on the different aspects of the disease.(2. Improvement in Quality of life)
研究者
Dr Shruthi S
Sri Sri College of Ayurvedic Science and Research
