CTRI/2019/05/018972尚未招募2 期
Effect of polyherbal formulation in the treatment of Osteoarthritis Knee Joint: a randomized single blind standard controlled trial.
Sayyed Abuzar Gaffari1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月23日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- reducing the pain from baseline to the end of treatment.
研究概览
简要总结
40eligible patients of Osteoarthritis Knee, after obtaining written informed consent will be randomlyallocated either to test (n=20) or control group (n=20). Patients will beblinded for the study. In the test group; Polyherbal formulation 7 gram in the form of majoon will be give once aday for 21 daysorally. In the control drug 1Tablet Aceclofenac 100mgwill be given orally morningand evening for 21 days. The follow upof patients will be done at 7th, 14th and 21th . Assessment ofsubjective parameters will be done on each visit and objective parameterswillbe assessed before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with primary osteoarthritis, fulfilling the ACR clinical/radiological classification criteria.
- •Patients of both genders between the age group of 35 to 65 years.
排除标准
- •Patients suffering with other forma of arthritis like, rheumatoid arthritis, rheumatic arthritis, psoriatic arthritis, ankylosing spondylitis gouty arthritis, infective arthritis, and systemic lupus erythematous (SLE).
- •â€¢Patients suffering from systemic diseases, like diabetes, endocrinal disorders, malignancies etc.
- •â€¢Patients with BMI ≥
- •Patients giving the History of recent accident or trauma.
- •Patients with severe restricted mobility.
- •Pregnant and lactating mothers.
结局指标
主要结局
reducing the pain from baseline to the end of treatment.
时间窗: 30 days
次要结局
- reducing the WOMAC score and improving the quality of life and also to assess its effect on other subjective parameters from baseline to end of treatment.(21 days)
研究者
研究点 (1)
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