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临床试验/CTRI/2019/12/022217
CTRI/2019/12/022217已完成2 期

An open labeled interventional clinical trial to evaluate the efficacy of Rhumed strong oil in the management of Osteoarthritis of knee joint.

Multani Pharmaceuticals Ltd New Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年2月12日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Assessment of pain

研究概览

简要总结

It is an open labeled, single armed, single center, prospective, interventional clinical study to evaluate the efficacy of the Rhumed strong oil on 50 patients suffering from osteoarthritis of knee joint. The study will be conducted in Panchakarma department, NIA, Jaipur, Rajasthan. It will be advised to subjects to apply the oil 2 times a day on the affected knee joint/s for 15 days. The primary outcome measure will be to assess the efficacy of Rhumed strong oil in patients of Joints pain by assessing the degree of pain on day 0, day 15 and day 22. The secondary outcome will be assess the changes in swelling, tenderness, stiffness and restricted movement in joint.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age: from 40-70 years of either sex Subjects with symptoms of Osteoarthritis of knee joint Subjects who are willing to give informed consent any ready to comply the protocol Subjects who are ready to provide regular follow up till the completion of the study.

排除标准

  • Patients of age below 40 years and above 70 years of either sex Patients having associated Pulmonary Tuberculosis, Burns, Open wounds and infective conditions, allergy, skin sensitivity , Knee joint replacement, Gouty arthritis, Rheumatoid arthritis etc.

结局指标

主要结局

Assessment of pain

时间窗: one year

次要结局

  • Changes in the degree of swelling, stiffness, restricted movement of the joints, tenderness and development of any adverse effect(one year)

研究者

发起方
Multani Pharmaceuticals Ltd New Delhi
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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