CTRI/2016/10/007348已完成未知
Evaluation of Efficacy, Safety and Tolerability of aCombination Therapy with Chlorzoxazone and Ibuprofencompared to Ibuprofen alone in the SymptomaticTreatment of Acute Low Back Pain (LBP): An Open-label,Prospective, Multi-center, Observational Study
Dr Reddys Laboratories Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Patient of either sex between 18 to 60 years of age
- •2. Symptomatic with acute low back pain, with or without
- •radiating pain no lower than the knee, for less than 3 days
- •3. Patients willing to take the medications as directed and
- •willing to come for the follow-ups
- •4. Willing to comply with the protocol requirements
- •5. Willing to give the written informed consent
排除标准
- •1. Patients associated with other lumbar or cervical spinal
- •tract conditions such as spondylitis, fracture, cancers, severe
- •arthritis and osteoporosis.
- •2. Muscular diseases such as myositis, poliomyositis, muscular
- •dystrophy and myotonia.
- •3. Other known systemic diseases affecting the neurological or
- •endocrine system.
- •4. 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).
- •5. Patients who had taken any form of skeletal muscle relaxant
- •in the previous 48 hours (2 days).
- •6. Pregnant / Lactating Woman or women of child bearing
- •potential not following adequate contraceptive measures.
- •7. Patients with known hypersensitivity to ingredients of
- •study/active comparators.
- •8. Patients with any previous H/O or current episode of cardiovascular
- •9. 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.
- •10. Uncontrolled diabetes mellitus or any other metabolic
- •11. Patients with H/O alcohol of substance abuse.
- •12. Treatment with any investigational drug in the preceding 4
- •13. Patients with active or recent history of, inflammatory
- •diseases of the gastrointestinal tract such as peptic ulcer,
- •gastritis, regional enteritis, or ulcerative colitis.
- •14. Patients in whom Acetyl Salicylic Acid (ASA) or other nonsteroidal
- •anti-inflammatory agents (NSAIDs) have induced
- •asthma, rhinitis, urticaria or other allergic manifestations.
- •15. Any other condition that, in the opinion of the investigator,
- •does not justify the inclusion of the subject in the study.
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