Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system
Conditions
Interventions
Intervention1: Aceclofenac IP 100 mg
Paracetamol IP 325mg
Serratiopeptidase IP 15 mg
: One tablet twice daily, to be administered orally after food Duration: 7 Days
Control Intervention1: Aceclofe
Sponsors
Pure & Cure Health Pvt. Ltd
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant, lactating women or women of childbearing age who are using an acceptable method of birth control. 2. Willing to give written informed consent. 3. Subjects suffering from acute painful conditions with spasm
Exclusion criteria
Exclusion criteria: 1. Patients known, or thought 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 judgment of the study personnel, would 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 for seizures or taking seizure drugs 7. 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 active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. 11. Patients with preexisting gallbladder disease 12. Active peptic ulcer disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in tenderness, joint mobility, muscle spasmTimepoint: Day 0,7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical global impression improvementTimepoint: Day 7;Change in pain intensity (PI-NRS)Timepoint: Day 0,7;subjects reporting adverse effectsTimepoint: Day 7;Vital signs & general examinationTimepoint: Day 0,7;Tolerability of study drugTimepoint: Day 7 | — |
Countries
India
Contacts
Public ContactDr Sayali Sadgune
Mudra Clincare
Outcome results
None listed