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临床试验/CTRI/2024/06/068474
CTRI/2024/06/068474尚未招募2 期

An open clinical trial to evaluate the therapeutic efficacy of Varma Kanji (Internal) and Lagu Vishamutti Thylam (External) with Varmam therapy in the management of Thandagavatham (Lumbar Spondylosis)

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Mean reduction in pain, numbness & restriction of movements of Thandagavatham patients with trial medicines

研究概览

简要总结

**INTRODUCTION :**Lumbar spondylosis is a chronic, noninflammatory disease caused by degeneration of lumbar disc and/or facet joints. It is common and worsens with age. In lumbar spondylosis, there is narrowing of the space between the vertebrae, causing a variety of health problems ranging from back pain to neurological issues. Pain or tingling symptoms that extend outward to the hip or down the leg can result from compression or inflammation of nerves, a condition referred to as lumbar radiculopathy. Nowadays, Low back pain is common among people who have sedentary lifestyle, obese, having job related risk factors that require heavy weight lifting, travelling to distant places or maintaining a poor sitting posture. The pooled point, annual, and lifetime prevalence of LBP in India was 48% (95% CI 40-56%); 51% (95% CI 45-58%), and 66%(95%CI 56-75%), respectively. The pooled prevalence rates were highest among females, therural population, and among elementary workers. The point, annual, and lifetime prevalence rates of LBP in the Indian population is higher compared to global and other ethnic populations. MATERIALS AND METHODS : A total of 30 patients within the age limit of 18 - 60 years willing to participate in the study by signing the consent form will be enrolled in the study. Both male and female patients will be enrolled. RESULTS AND DISCUSSION : Reduction of clinical symptoms of lumbar spondylosis through Aberdeen low back pain scale and the results will be statistically analysed.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • 60 years 2.Sex: Male, Female and Transgender 3.Score between
  • 80 % in ABERDEEN LOW BACK PAIN SCALE 4.Patients willing to give radiological investigation and provide blood sample for lab investigation 5.Patient willing to sign Informed Consent.

排除标准

  • 1.Ankylosing spondylitis 2.K/C/o Trauma 3.Spondylolisthesis 4.Vertebral fracture 5.Tumour in Lumbar Vertebra 6.K/C/o TB 7.K/C/o Disc Prolapse.

结局指标

主要结局

Mean reduction in pain, numbness & restriction of movements of Thandagavatham patients with trial medicines

时间窗: 18 months

次要结局

  • Aberdeen low back pain scale score reduced to 20%(Screening - 6 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR V P Gaayathri

National Institute of Siddha

研究点 (1)

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