A Controlled Labeled, Randomized Prospective, Multicentric Parallel Group, Phase-III Clinical Trial to Compare Efficacy and Safety for FDC of Eperisone150mg SR and Diclofenac 100mg SR capsule OD with Eperisone 50 mg EC Tablet T.I.D in Subjects suffering with Acute Musculoskeletal Spasm Associated With Low Backache.

Inventia Health Care Pvt. Ltd.0 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

暂无简介。

•Ages Eligible for Study: 18 Years to 70 Years
•Genders Eligible for Study: Both
•Accepts Healthy Volunteers: No
•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 & spasm associated with fractured bone.
•Patients who had taken any form of skeletal muscle relaxant in the previous 7 days.
•Patients with hypersensitivity to any of the ingredients of the study drug formulations.
•Pregnant or Lactating women or 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 or trauma, severe
•metabolic, endocrine or electrolyte disturbances and seizures in preceding 8 weeks.
•Patients having any of the following disorders: Renal failure, Bulimia, Hypo and Hyperthyroidism Nephrotic syndrome.
•Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder.
•Patients that have received treatment with any investigational drug in the preceding 4 weeks.
•Patients likely to be non-compliant.

发起方

Inventia Health Care Pvt. Ltd.