Evaluate The Efficacy of Panchkarma Protocol in The Management of Kampavata (Parkinson’s Disease) An Open Labelled Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in Serum Dopamine level.
研究概览
简要总结
This clinical trial is designed to evaluate the efficacy of a Panchakarma protocol—comprising Virechana, Karma Basti, and Shirobasti followed by Brihmana Snehapana with Masha Taila—in the management of Kampavata (Parkinson’s Disease). The study is an open-label, randomized, controlled, double-arm interventional trial to be conducted at the Department of Panchakarma, National Institute of Ayurveda, Jaipur. A total of 70 patients aged 30–70 years with clinical features of Kampavata, including bradykinesia, tremors, rigidity, postural changes, and gait disturbances, will be enrolled. Patients will be randomly allocated into two groups: Group A receiving Panchakarma protocol with Masha Taila-based interventions, and Group B receiving standard control (Levodopa-Carbidopa therapy). The intervention will be carried out over 75 days with a 30-day follow-up. Primary outcome measures include changes in serum dopamine levels, while secondary outcomes include improvements in Unified Parkinson’s Disease Rating Scale (UPDRS), symptom severity (Kampa, Stambha, Chestasanga, Vakvikriti, Avanamana, Gatisanga), and quality of life (PDQ-8). Statistical analysis will be performed using both parametric and non-parametric methods, with significance set at p<0.05. The trial aims to establish whether Panchakarma therapy provides superior clinical benefits compared to standard therapy in Parkinson’s disease.
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
- 30.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with clinical signs and symptoms of Kampavata(Parkinson’s Disease).
- •Controlled diabetes and hypertension cases to be taken with conventional medicine.
- •Preferably freshly diagnosed cases as well as cases of Kampavata(Parkinson’s Disease) with a chronicity of less than 10 years with persisting symptoms despite allopathy medications.
- •Patients willing to participate for an interventional study.
排除标准
- •Patients unfit for Virechana, Basti and Shirobasti.
结局指标
主要结局
Changes in Serum Dopamine level.
时间窗: Day 0 (Baseline), After 75 Days of Intervention
次要结局
- 1. Changes in UPDRS score(2. Changes in symptoms like Kampa, Chestasanga (Akinesia and Bradykinesia), Stambha, Avanamana, Vakvikruti and Gatisanga.(As per Assessment Scale mentioned in CRF))
研究者
Dr Ajay Kumar Yadav
National Institute of Ayurveda, (DU), Jaipur.
