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临床试验/CTRI/2025/04/085600
CTRI/2025/04/085600尚未招募2 期

Evaluation of the Therapeutic Effect of Siddhar Yogam with and without Vilvathi Legiyum in the management of Thandagavadham (Lumbar Spondylosis) in Patients Reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha, - A Randomized, Double Arm, Single Centric Comparative Clinical Trial

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
The outcome of the study will assessed by using Oswestry Disability index and expected

研究概览

简要总结

Lumbar spondylosis is a common degenerative condition affecting a significant population, causing pain, disability, and reduced quality of life. Yoga is generally believed to improve flexibility, strength, balance, and agility. Most people experience low back pain at some point in their lives. The peak in the number of cases occurs at 50–55 years, and women experience low back pain more frequently than men. The prevalence and disability impact of low back pain are greatest among older people aged 80–85 years.  For patients with low back pain yoga appears to address imbalances in the musculoskeletal system affecting spinal alignment and posture. Yoga has been shown to reduce chronic low back pain and disability in patients with lumbar spondylosis. Regular practice improves spinal flexibility and strength, enhancing functional ability. Recent research has also indicated that yoga can reduce pain catastrophizing, increase pain acceptance and improve overall emotional functioning among individuals with chronic pain. The raw drugs used in  Vilvathi Legiyum has Anti- Inflammatory , analgesic, antioxidant, hepatoprotective, immunomodulatory activities. This study aims to study the effect of Siddhar Yogam with and without Vilvathi Legiyum for the management of Lumbar spondylosis (Thandagavadham) by using Oswestry Disability Index. As per the inclusion criteria, 40 patients will be included in this trial. The selected patients will be divided into two groups. Group A: Siddhar Yogam for 20 patients  Group B: Siddhar Yogam and Vilvathi Legiyum for 20 patients.I nformed consent will be obtained from each patient. Group A Patients will be taught selected Siddhar Yogam and for Group B patients the trial drug Vilvathi Legiyum 140 gms will be given once in 7 days and Siddhar Yogam will be taught and advised to follow for 48 days.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Oswestry Disability index score 15.

排除标准

  • K/C/O Uncontrolled Hypertension K/C/O Rheumatoid arthritis K/C/O Uncontrolled diabetes K/C/O Cardiac disorders K/C/O Osteoporosis Pregnancy and lactation Tuberculosis in spine Osteomyelitis Ankylosing spondylitis Spine deformity Pyogenic bone infection Patients with recent surgical and traumatic history.

结局指标

主要结局

The outcome of the study will assessed by using Oswestry Disability index and expected

时间窗: Baseline, once in 7 days upto 49th day

reduction in the score will interpreted as

时间窗: Baseline, once in 7 days upto 49th day

Moderate disability (15-24) to Mild disability (5-14)-Moderate improvement

时间窗: Baseline, once in 7 days upto 49th day

Moderate disability (15-24) to No disability (0-4)-Significant improvement

时间窗: Baseline, once in 7 days upto 49th day

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

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