Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system
Conditions
Interventions
Intervention1: Aceclo SERA: Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg
Treatment- 7 days
Control Intervention1: Aceclo Plus: Fixed dose co
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 suffering from acute pain with spasm such as prolapsed intervertebral disc, sprains and dislocations, spondylosis ( Lumbar, cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low back pain, tendonitis, tenosynovitis, bursitis. 3. Patients 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, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of ACECLO-SERA (Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg plus Serratiopeptidase 15 mg tablet versus ACECLO PLUS Fixed dose combination tablet of Aceclofenac 100 mg plus Paracetamol 325 mg in the treatment of acute painful musculospastic conditions.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 & tolerability of ACECLO-SERA (Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg plus Serratiopeptidase 15mg tablet versus ACECLO PLUS Fixed dose combination tablet of Paracetamol 325 mg plus Aceclofenac 100 mg in the treatment of acute painful musculospastic conditions.Timepoint: Visit 1 Day 0 Screening and enrollment. Visit 2 Day 4 follow up visit. Visit 3 Day 7 End of study | — |
Countries
India
Contacts
Public ContactDr Mahendra Chaudhari
ARISTO Pharmaceuticals Private Limited
Outcome results
None listed