Health Condition 1: M150- Primary generalized (osteo)arthritis
Conditions
Interventions
Intervention1: FDC of Aceclofenac (100 mg) + Paracetamol (325 mg) + Serratiopeptidase (15 mg): Aceclofenac (100 mg) + Paracetamol (325 mg) + Serratiopeptidase (15 mg)
Dose: Aceclofenac (100 mg) + Para
Sponsors
Albert David Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged more than 18 years and less than 60 years (both inclusive) 2. Willing to give 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.
Exclusion criteria
Exclusion criteria: 1.Subjects with known hypersensitivity to any of the study drugs. 2.History of autoimmune 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 the inclusion. 5.Participation in another clinical trial in the last three months and during study participation 6.Subjects 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.Subjects with Galactose or fructose intolerance. 8.Subjects with severe renal impairment, including those receiving dialysis 9.Subjects with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. 10.Subjects with pre-existing gallbladder disease. 11.Active peptic ulcer disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Pain reduction on day 7 of treatment by assessing pain intensity using the PI NRS scale, compared to baseline PI NRS scale. 2.Change or Improvement in the CGI scale from baseline to the end of the treatment.Timepoint: Day 1, Day 3, Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of adverse events (AEs) and serious adverse events (SAEs). 2.Pain relief with study medication on days 1, 3 and day 7 by using PI NRS scale. Timepoint: Day 1, Day 3, Day 7 | — |
Countries
India
Contacts
Public ContactDr Veena Venkatesh
Albert David Limited
Outcome results
None listed