Randomized controlled clinical study to evaluate efficacy of bruhatlashunpinda and rasnasaptak kwatha in the management of manyastambha with special reference to cervical spondylosis.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in Visual Analog Scale, Neck Disability Index, Goniometry readings and neck pain, stiffness, restricted neck movements.
研究概览
简要总结
TITLE OF DISSERTATION
RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE EFFICACY OF BRUHATLASHUNPINDA AND RASNASAPTAK KWATHA IN THE MANAGEMENT OF MANYASTAMBHA WITH SPECIAL REFERENCE TO CERVICAL SPONDYLOSIS.
AIMS AND OBJECTIVES
AIMS-
To study and compare the effect of Bruhatalashunapinda and Rasnasaptak kwatha in the management of Manyastambha with special reference to Cervical spondylosis.
OBJECTIVES-
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To evaluate efficacy of Bruhatalashunapinda in the management of Manyastambha with special reference to cervical spondylosis.
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To evaluate efficacy of Rasnasaptak kwatha in the management of Manyastambha with special reference to cervical spondylosis.
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To study Manyastambha in detail according to Ayurved Samhita and cervical spondylosis according to modern view.
HYPOTHESIS
NULL HYPOTHESIS-
Effect of Bruhatalashunapinda is not significant than Rasnasaptak kwatha in the management of Manystambha with special reference to cervical spondylosis.
ALTERNATE HYPOTHESIS-
Effect of Bruhatalashunapinda is significant than Rasnasaptak kwatha in the management of Manystambha with special reference to cervical spondylosis.
RESEARCH QUESTION
PRIMARY RESEARCH QUESTION
Is there any significant difference between Bruhatlashunpinda and Rasnasaptak kwatha in the management of Manyastambha with special reference to Cervical spondylosis?
SECONDARY RESEARCH QUESTION
Is Bruhatlashunpinda is effective in the management of Manyastambha with special reference to Cervical spondylosis?
METHOD OF COLLECTION OF DATA
Considering 20% Dropout rate, we propose to enroll 72 subjects (36 in each group) to get 60 evaluable cases (30 in each group) at the end of the study. These subjects will be fulfilling inclusion Criteria, which will be selected from D.Y. Patil Ayurvedic Hospital Nerul Navi Mumbai OPD No.1 and IPD (Kayachikitsa department) and randomly divided into two groups –Group A and B. Group A subjects will be treated with Bruhatalashunapinda and Rasnasaptak Kwatha and Group B Subjects will be treated with Rasnasaptak Kwatha (Control group) for 28 days. levels of improvement will be recorded in three visits v1,v2,v3. Each visit will be 7 days apart.
DIAGNOSTIC CRITERIA
1) Pain (Ruja)
2) Stiffness (Stambha)
3) Restricted neck movements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Well diagnosed patients of manyastambha (Cervical spondylosis).
- •2.Subjects having neck pain with or without radicular symptoms paresthesia since more than two months.
- •3.Cervical spondylitis confirmed by radiological assessment (X ray cervical vertebrae AP and lateral view.
- •4.Subjects were willing to give informed consent and ready to comply with the protocol.
- •5.Subjects who are ready to provide regular follow ups till completion of the study.
排除标准
- •1.Known cases of trauma of neck, local wound and infection over neck, cervical rib syndrome, any spinal cord disorders other than cervical spondylosis & myelopathy.
- •2.Known cases of shoulder and elbow musculoskeletal problems, fracture of spine and upper limb.
- •3.Known cases of inflammatory arthritis.
- •4.Subjects who use any other investigational drug within one month prior to randomization.
- •5.Known cases of Tuberculosis, HIV, Ischemic heart disease, Cancer.
- •6.Known cases of Hypertension, Hyperacidity, Peptic ulcer, Duodenal ulcer.
- •7.Pregnancy and Lactation.
- •8.Other conditions, which in the opinion of investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
Improvement in Visual Analog Scale, Neck Disability Index, Goniometry readings and neck pain, stiffness, restricted neck movements.
时间窗: 4 weeks
次要结局
未报告次要终点