A Double-blind, Randomized, Multicentric, Comparative, Phase IV clinical trial to evaluate efficacy, safety & Tolerability of oral tablets of fixed dose combination of Aceclofenac 100 mg + Paracetamol 325 mg + Serratiopeptidase 15 mg in comparison with Aceclofenac 100 mg + Paracetamol 325 mg tablets in the treatment of acute painful musculospastic conditions. - NI

Albert David Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•1. Male or female aged more than 18 years and less than 60 years (both inclusive)
•2. Willing to give written informed consent
•3. Subjects suffering from acute painful conditions with spasm such as prolapsed intervertebral disc, sprains and dislocations, spondylosis (Lumbar, Cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low backpain, tendonitis, tenosynovitis, bursitis.

•1.Subjects with known hypersensitivity to any of the study drugs.
•2.History of autoimmune disease.
•3.Concurrent use of corticosteroids.
•4.Any medication or indication that might point to an increased risk. Associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel. Make the subject inappropriate for the inclusion.
•5.Participation in another clinical trial in the last three months and during study participation
•6.Subjects with history of epilepsy, or those at-risk seizures or taking seizure drugs in pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control
•7.Subjects with Galactose or fructose intolerance.
•8.Subjects with severe renal impairment, including those receiving dialysis
•9.Subjects with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
•10.Subjects with pre-existing gallbladder disease.
•11.Active peptic ulcer disease

发起方

Albert David Limited