CTRI/2016/03/006702已完成2 期
A Randomized, Single Blind, Prospective, Multi-center, Phase II, Clinical Study to evalaute efficacy and safety of three different topical formulations in subjects suffering from Backache. - NI
Emami Ltd0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Low Back Pain without any serious medical/surgical condition for a minimum period of six months.
- •2.History of Low Back Pain requiring the use of NSAIDs Acetaminophen, or another analgesic agent on a regular basis for at least six months before the screening visit
- •3.Subjects not having severe Lumbar joint deformity
- •4.Subjects signing written informed consent and ready to comply with the protocol requirement
- •5.Subjects with pain VAS > 40 mm on weight bearing activities
排除标准
- •1.Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
- •2.Subjects requiring Spine surgery within 6 months of screening
- •3.Use of any other investigational drug within 1 month prior to randomization
- •4.Subjects having uncontrolled diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease
- •5.Known other active and serious medical or surgical disease
- •6.Pregnancy and Lactation
- •7.Known hypersensitivity to ingredients used in study drug
研究者
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