Health Condition 1: M629- Disorder of muscle, unspecified
Conditions
Interventions
Intervention1: Diclofenac Soodium IP 50/50 mg Paracetamol IP 325/325 mg Chlorzoxazone IP 250/ 500 mg: One tablet twice daily, to be administered orally after food
Intervention2: Diclofenac Sodium IP 5
Sponsors
Jenburkt Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Willing to give written informed consent 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 bursistis, spondylilistheisis, Low-back pain, Tendonitis, Tenosynovitis, Bursitis.
Exclusion criteria
Exclusion criteria: Patients known, or thought to be hypersensitivity to study drugs History of auto-immune disease Excluded medications are corticosteroids 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, would make the subject inappropriate for inclusion Participation in other clinical trials the last three months and during study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical global impression- Improvement Change in Pain intensity (on PI-NRS)Timepoint: 0-7 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of Tenderness, Joint mobility, Muscle Spasm on VAS (1-10 scale) from baseline to final assessment, as assessed by the investigatorTimepoint: 0-7 Days | — |
Countries
India
Contacts
Public ContactDr Saiprasanna Behera
CRO PHARMATRENDZ PVT. LTD.
Outcome results
None listed