A Phase IV, Prospective, Open Label, Multi-centric, Randomized, Comparative Clinical Study to Evaluate the Efficacy and Safety of FDC of Chlorzoxazone 500 mg, Diclofenac Potassium 50 mg, Paracetamol 325 mg Tablets compared to FDC of Diclofenac Potassium 50 mg and Paracetamol 325 mg tablet for the treatment of Acute Musculoskeletal Spasm. - NI

G S Pharmabutor Pvt Ltd Co Win Medicare Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•1.Male/Female patients aged between 18-65 years with a clinical diagnosis of acute musculoskeletal spasm.
•2. Muscle Spasm persistent since last 24 hours at the time of presentation to the investigator.
•3.Patients with at least moderate pain at rest of Numeric rating Scale (NRS) greater or equal to 4.
•4.Patient with presence of muscle spasm scoring greater than 1
•5.Willingness to comply with the study schedule and procedures.
•6.Patient is willing to provide written informed consent prior to study.

•1.Pregnant and Lactating mothers.
•2.Patients with painful muscle spasms that require parenteral therapy/ surgery/ hospital admission for management.
•3.Patient history suggestive of any degenerative/autoimmune/nervous system related disease conditions.
•4.Use of any oral or topical analgesic or anti-inflammatory medicine 48 hours prior to development of acute musculoskeletal spasm.
•5.Patients with history of severe cardiac/hepatic/gastrointestinal/ pulmonary impairment.
•6.Known hypersensitivity to any ingredient of the study drug.
•7.Concomitant Participation in any other clinical trial or in last 90 days.
•8.History of regular fever, headache or any other disease that warrants frequent use of Paracetamol or NSAIDS.
•9.Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion.

发起方

G S Pharmabutor Pvt Ltd Co Win Medicare Pvt Ltd