Health Condition 1: M629- Disorder of muscle, unspecified
Conditions
Interventions
Intervention1: Aceclo MR: Aceclofenac IP 100mg Plus Paracetamol IP 325mg plus Cholorzoxazone USP 500mg
Duration: 7 days
Control Intervention1: Aceclo Plus: Aceclofenac IP 100mg plus Paracetamol IP 32
Sponsors
Aristo Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender between 18 and 60 years of age (inclusive of both). 2. Patients of acute musculoskeletal pain with spasm having VAS score = 40 (on 100 mm VAS scale) 3. Patients who are willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with known 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 judgment 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 of seizures or taking seizure drugs. 7. In pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 8. Patients with galactose or fructose intolerance. 9. Patients with severe renal impairment, including those receiving dialysis. 10. Patients with pre-existing gallbladder disease. 11. Active peptic ulcer disease or history of peptic ulcer, bleeding disorder and fecal blood loss. 12. Patients taking muscle relaxants, NSAIDs (anti-inflammatory drugs) and pain relievers within last 14 days. 13. Patients with significant cardiac, hepatic dysfunction, and hematologic disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of ACECLO MR Tablet Fixed-dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg plus Chlorzoxazone 500mg versus ACECLO PLUS Tablet Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg in the treatment of acute musculoskeletal pain associated with spasm.Timepoint: Visit 1 Day 0 Screening and enrollment. Visit 2 Day 4 Follow up visit. Visit 3 Day 7 End of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety of ACECLO MR Tablet (Fixed-dose combination tablet of Aceclofenac 100mg + Paracetamol 325mg + Chlorzoxazone 500mg) versus ACECLO PLUS® Tablet (Fixed dose combination tablet of Aceclofenac 100mg +Paracetamol 325mg) in the treatment of acute musculoskeletal pain associated with spasm. Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactDr Mahendra Chaudhari
ARISTO Pharmaceuticals private limited.
Outcome results
None listed