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临床试验/CTRI/2024/05/067313
CTRI/2024/05/067313尚未招募3 期

A Prospective Randomised Two Arm Parallel Clinical Study to Compare the Results of Polarity Analysis method and Conventional Homoeopathic method in the treatment of Lumbar Spondylosis

Nehru Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1.Roland-Morris disability questionnaire.

研究概览

简要总结

This is a Prospective Randomised Two Arm Parallel Clinical Study to Compare the Results of Polarity Analysis method and Conventional homoeopathic method in the treatment of lumbar spondylosis. 60 patients suffering from lumbar spondylosis will be randomized into 2 groups consisting of 30 in each group. Study will be of 1 year duration. Improvement in back pain and disability will be assessed using Roland-Morris disability questionnaire and Numerical pain rating scale for back pain.

RESEARCH QUESTION:

Is there any significant difference between the two comparable groups i.e.,Results obtained by Polarity analysis method and conventional homoeopathic method in the treatment of lumbar spondylosis?

Null hypothesis- There will be no significant difference between the two comparable groups i.e.,Results obtained by Polarity analysis method and conventional homoeopathic method in the treatment of lumbar spondylosis

Alternative hypothesis- There will be significant difference between the two comparable groups i.e.,Results obtained by Polarity analysis method and conventional homoeopathic method in the treatment of lumbar spondylosis

AIM

To Compare the Results of Polarity Analysis method and Conventional homoeopathic method in the treatment of lumbar spondylosis

OBJECTIVES

  1. To assess the effect of individualized homoeopathic medicines in the treatment of lumbar spondylosis and to find out most frequently indicated medicines in lumbar spondylosis

  2. To assess and compare the initial and final NUMERICAL PAIN RATING SCALE score and ROLAND-MORRIS DISABILITY QUESTIONNAIRE score in patients who receive individualized Homeopathic Medicine by Polarity Analysis method and Conventional homoeopathic method in the treatment of lumbar spondylosis.

  3. To find out most frequently indicated polar symptoms in patients of lumbar spondylosis.

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
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting with clinical features of lumbar spondylosis with or without radiculopathy
  • Diagnosis confirmed by X-Ray of lumbar spine (AP and Lateral view) showing changes of lumbar spondylosis
  • Patients giving written consent to participate in the study.

排除标准

  • Patients with severe disability and who needs surgical intervention.
  • Previous back surgery.
  • Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness or any organ failure.
  • Pregnancy and lactation.
  • Substance abuse and/or dependence.
  • 7.Self-reported immune-compromised state.
  • Simultaneous participation in any other trial.

结局指标

主要结局

1.Roland-Morris disability questionnaire.

时间窗: At baseline and after 3 months

2.Numerical pain rating scale for back pain

时间窗: At baseline and after 3 months

次要结局

未报告次要终点

研究者

发起方
Nehru Homoeopathic Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Dolly M

Nehru Homoeopathic Medical College and Hospital

研究点 (1)

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