CTRI/2010/091/002934已完成3 期
Evaluation of Efficacy and Tolerability of a Fixed dose combination of Eperisone hydrochloride and diclofenac sodium in the treatment of acute musculo-skeltal spasm associated with low back pain: An Observer Blind, Prospective, randomized, controlled study
Eisai Pharmaceuticals India Private Limited, 1st Floor, B-Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri East, Mumbai - 4000720 个研究点目标入组 240 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
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
- •Patient of either sex between 18 to 60 years of age
- •- Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to any of the following causes:
- •1.Spondylosisdeformans
- •2.Prolapsed Intervertebral Disc (PID)
- •3.Muscle Sprains with spasms
- •- Patients willing to take the medications as directed and willing to come for the follow-ups
- •- Willing to comply with the protocol requirements
- •- Willing to give the written informed consent
排除标准
- •- Patients associated with other lumbar spinal tract conditions such as spondylitis, fracture, cancers, severe arthritis and osteoporosis.
- •- Muscular diseases such as myositis, poliomyositis, muscular dystrophy and myotonia.
- •- Other known systemic diseases affecting the neurological or endocrine.
- •- Patients with moderate to severe hepatic impairment (defined as increase in serum bilirubin, SGOT & SGPT by >2.5 times the upper reference level of the laboratory values) and renal impairment (defined as increase in serum creatinine and Blood urea nitrogen by >2.5 times the upper reference level of the laboratory values).
- •- Patients who had taken any form of skeletal muscle relaxant in the previous 7 days.
- •- Pregnant / Lactating Woman or women of child bearing potential not following adequate contraceptive measures.
- •- Patients with known hypersensitivity to ingredients of study/active comparators.
- •- Patients with any previous H/O or current episode of cardio-vascular disorders.
- •- Subject known to be having any of the following disorder: Renal failure, Bulimia, Hypo and hyperthyroidism, Nephrotic Syndrome, Anorexia nervosa, Biliary obstruction, severe cardiac dysfunction.
- •- Uncontrolled diabetes mellitus or any other metabolic disorder.
- •- Pediatric and Pregnant patients.
- •- Patients with H/O alcoholic/substance abuse.
- •- Treatment with any investigational drug in the preceding 4 weeks.
- •- Patients with active or recent history of, inflammatory diseases of the gastrointestinal tract such as peptic ulcer, gastritis, regional enteritis, or ulcerative colitis.
- •- Patients in whom Acetyl Salicylic Acid (ASA) or other non-steroidal anti-inflammatory agents (NSAIDs) have induced asthma, rhinitis, urticaria or other allergic manifestations.
- •- Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
研究者
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