Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
None listed
Sponsors
Pravek Kalp (P) Limite
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of either sex in the age range of 18 to 60 years (both inclusive) 2. Subjects able and willing to give written informed consent form. 3. Subjects suffering from acute pain and inflammation associated with 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.
Exclusion criteria
Exclusion criteria: 1. Subjects known, or thought to be hypersensitivity to study drugs 2. Subjects with concurrent use of corticosteroids 3. Subjects with 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 in appropriate for inclusion 4. Subjects participated in other clinical trials from last three months or during study participation 5. Subjects with history of epilepsy or at risk of seizures or taking anti-epileptic drugs 6. Pregnant, lactating women or women of child bearing 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 gall bladder disease 11. Subjects with active peptic ulcer disease 12. Pre or post-surgical cases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Improvement in Clinical Global Impression scale (CGI) • Improvement in tenderness, joint mobility and muscle spasm associated pain from baseline to final assessment, measured by the Pain Intensity Numeric Rating Scale (PI-NRS) • Incidence of adverse events (Clinical signs, symptoms, vitals, laboratory parameters) • Incidence of adverse events of interest • Determination of type, frequency, severity, and relationship of reported adverse effects to the study treatment Timepoint: Screening,Day-0,Day-30,Day-60,Day-90 and Day-97 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Improvement in Clinical Global Impression scale (CGI) • Improvement in tenderness, joint mobility and muscle spasm associated pain from baseline to final assessment, measured by the Pain Intensity Numeric Rating Scale (PI-NRS)Timepoint: Screening,Day-0,Day-30,Day-60,Day-90 and Day-97 | — |
Countries
India
Contacts
Public ContactRanjeet Roy
Pravek Kalp Private Limited
Outcome results
None listed