A Control- Labeled, Prospective, Randomized, Parallel group, Multicentric, Phase III Clinical Trial to Evaluate Efficacy and Safety of Eperisone HCl SR Capsule compared with Eperisone HCl Tablet in patients suffering from Acute Musculoskeletal Spasm associated with Low Back Pain.

Inventia Health Care Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients of either sex between 18 to 70 years of age.
•Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to:
•Spondylosis deformans.
•Prolapsed Intervertebral Disc (PID).
•Muscle sprains with spasms.
•Patients who are willing to take the medications as directed and willing to come for follow-ups.
•Patients who are willing to comply with the protocol requirements.
•Patients who are willing to give the written informed consent.

•Patients with other associated spasm conditions like traumatic pain with spasms, cervical spondylitis and pain and spasm associated with fractured bone.
•Patients who had taken any form of skeletal muscle relaxant in the previous seven days
•Patients with hypersensitivity to any of the ingredients of the study drug formulations.
•Women of child bearing potential not following adequate contraceptive measures
•Patients unwilling or unable to comply with the study procedures
•Patients having a history of severe acute infection, major surgery, trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding eight weeks
•Patients having severe hepatic insufficiency defined by an SGOT or SGPT value equal or higher than the three fold normal values of the respective laboratory reference value
•Patients having any of the following disorders: Renal failure, Bulimia, Hypo and Hyperthyroidism, Nephrotic syndrome, Anorexia nervosa, biliary obstruction and severe cardiac dysfunction.
•Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder
•Patients that have received treatment with any investigational drug in the preceding four weeks

发起方

Inventia Health Care Pvt Ltd