A Randomised Comparative Clinical Study To Evaluate The Effect Of Lashuna [Allium sativum linn.] And Vruddhadaru [Argyreia speciosa sweet.] Rasayana In Gridhrasi W.S.R. To Inter Vertebral Disc Prolapse.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changed in the signs and symptoms of Gridhrasi.
研究概览
简要总结
This is a Randomised, open label, parallel group study comparing the safety and efficacy of Lashuna rasayana [group A] 10000 mg daily and the Vruddhadaru Rasayana [group B] 10000 mg daily for 15 days for 15 patients in each group and will be conducted in Shri Dharmasthala Manjunatheshwara college of Ayurveda, Hospital and Research centre, Kuthpady, Udupi, Karnataka, India. The primary measures will be assessed through Sugar baker and barofsky clinical mobility scale and Oswestry disability assessment questionnaire and secondary measures assessed through SLR test, and Herron and Turners rating. Hence, this clinical study has planned an effort to prove the efficacy of Lashuna Rasayana and Vruddhadaru Rasayana as effective against Gridrasi W.S.R. to Inter vertebral disc prolapse.
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
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients fulfilling the diagnostic measures.
- •Patients between the age groups of 18-70 years.
- •Patients with radiological evidence of Inter vertebral disc prolapse in MRI.
- •Subjects who are willing to sign the informed consent form to participate in the research.
排除标准
- •Patients with radiological evidence of fracture of vertebrae, congenital deformities, neoplastic conditions of the spine, infections of the spine, cervical inter vertebral disc prolapse, spondylolisthesis and ankylosing spondylitis.
- •Any other systemic diseases which will interfere the treatment.
- •People who are contraindicated for intake of Lashuna.
- •Pregnancy and lactating mother.
- •Had participated in any clinical trial within 3 months of screening.
结局指标
主要结局
Changed in the signs and symptoms of Gridhrasi.
时间窗: 0 day | 17 days | 45 days
Changes in Sugar baker & Barofsky Clinical Mobility Scale and Oswestry Disability assessment questionnaire score.
时间窗: 0 day | 17 days | 45 days
Objective
时间窗: 0 day | 17 days | 45 days
SLR Test
时间窗: 0 day | 17 days | 45 days
Neurological deficit
时间窗: 0 day | 17 days | 45 days
次要结局
- Objective(SLR Test)
研究者
Dr Akhila K S
Rajiv Gandhi University Of Health Sciences, Bengaluru
