Evaluation of comparative efficacy of Granthikadi Taila Anuvasana Vasti versus Mahamasha Taila Anuvasana Vasti and Erandamooladi Niruha Vasti (Yoga Vasti) in both groups in the management of Thrombotic Stroke (Pakshaghata): A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Granthikadi Taila Anuvasana Vasti and Erandamooladi Niruha Vasti Versus Mahamasha Taila Anuvasana Vasti and Erandamooladi Niruha Vasti (Yoga Vasti) through Dynamic Gait Index, Berg Balance Scale, Barthel Index and NIHSS in patients with Thrombotic Stroke (Pakshaghata)
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial. It will include a 8 days treatment period and a follow up period of 0th, 8th and 24th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to provide written informed consent and abide by the instructions Patients with Thrombotic Stroke (Pakshaghata) recently diagnosed through MRI brain [15 days to 6 months] Patients with Thrombotic Stroke (Pakshaghata) of either gender aged between 21-70 years Patients fit for Anuvasana Vasti and Niruha Vasti.
排除标准
- •Patients having Cardiac Disease like AMI, Angina, etc Patients having DM.
- •Neuropathy, Retinopathy Pregnant and Lactating women Patient with Acute complications like Cirrhosis of the liver, Pancreatitis, and Hypoglycemic shock Patient with haemorrhagic stroke Patients with known brain space-occupying lesions such as tumors, abscesses, or cysts Patients having unControl Hypertension [Systolic BP more than 140 and Diastolic BP more than or equal to 90 mmHg] and unControl Diabetes Mellitus[FBS more than 130mg per dl ,PPBS more than 180 mg per dl].
结局指标
主要结局
To assess the efficacy of Granthikadi Taila Anuvasana Vasti and Erandamooladi Niruha Vasti Versus Mahamasha Taila Anuvasana Vasti and Erandamooladi Niruha Vasti (Yoga Vasti) through Dynamic Gait Index, Berg Balance Scale, Barthel Index and NIHSS in patients with Thrombotic Stroke (Pakshaghata)
时间窗: at baseline | 8 days | 24 days
次要结局
- Comparison and assessment of Granthikadi Taila Anuvasana Vasti and Erandamooladi Niruha Vasti Versus Mahamasha Taila Anuvasana Vasti and Erandamooladi Niruha Vasti (Yoga Vasti) through Dynamic Gait Index Berg Balance Scale Barthel Index and NIHSS in patients with Thrombotic Stroke (Pakshaghata)(at baseline)
研究者
Dr Ram Prakash Verma
Mahatma Gandhi Ayurvedic College Hospital and Research Centre