Health Condition 1: M628- Other specified disorders of muscle
Conditions
Interventions
Intervention1: FDC of Aceclofenac 100 mg, Paracetamol 325 mg and Serratiopeptidase 15 mg Tablets: Patients will be advised to take the study medication orally, swallowed as a whole with water twice da
Sponsors
Synokem Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of 18 years and 60 years (both Inclusive), 2. Willing to provide 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. 4. Patients willing to comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Patients known, or to be hypersensitivity to study drugs. 2. History of auto-immune 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 judgement of the study personnel. Make the subject inappropriate for inclusion. 5. Participation in other clinical trials the last three months and during study participation. 6. Patients 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. Patients with galactose or fructose intolerance. 8. Patients with severe renal impairment, including those receiving dialysis. 9. Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. 10. Patients with pre-existing gallbladder disease. 11. Active peptic ulcer disease. 12. Patients with chronic and degenerative conditions of pain. 13. Patients with the history of significant cardiovascular disorders, central nervous system disorders, endocrine disorder and other severe condition like asthma, uncontrolled hypertension and collagen disorders that may affect patient safety or difficult to evaluate the efficacy of the product. 14. Patients who have participated in any clinical trial in the past one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical global impression- Improvement (CGI-I) on a 7-point scale, pain intensity on a 11-point numerical rating scale (PI-NRS) will be measured from baseline to end of the study.Timepoint: Screening Visit (Visit 1), Visit 2 / Day 1, Visit 3 / Day 4 and End of Study (Visit 4 / Day 7). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the inflammatory markers (C-reactive protein) from baseline to end of the study.Timepoint: Screening Visit (Visit 1), Visit 2 / Day 1, Visit 3 / Day 4 and End of Study (Visit 4 / Day 7).;Adverse events reported during the study.Timepoint: Throughout the study.;Serious adverse events reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from baseline to end of the study visit.Timepoint: Screening Visit (Visit 1) and End of Study (Visit 4 / Day 7). | — |
Countries
India
Contacts
Public ContactDr Aditya Kaushik
Synokem Pharmaceuticals Ltd.
Outcome results
None listed