None listed
Conditions
Interventions
Intervention1: Etodolac and Thiocolchicoside: 300 mg and 4mg respectively
Control Intervention1: Thiocolchicoside: 4 mg
Sponsors
M/s. Ravenbhel Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of either sex of age  18 and  60 years [both inclusive] Willing to give written informed consent 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 bursistis, spondylilistheisis, Low-back pain, Tendonitis, Tenosynovitis, Bursitis.
Exclusion criteria
Exclusion criteria: Subjects currently on any other NSAID therapy. Subjects who are unresponsive to conservative medical therapy due to severe symptoms and who require different pain medication ere excluded from the study. Subjects with a history of known hypersensitivity from any one of the study medication. Subjects with hepatic, renal, respiratory illness. Subjects with active peptic ulcer disease. Subjects presently having active GERD. Subjects with history of bleeding tendencies, internal bleeding. Subjects with anemia. Subjects with uncontrolled hypertension. Subjects with congestive heart failure. Pregnant and Lactating women. Participation in a clinical trial with an investigational agent during the past 30 days. Simultaneous participation in a clinical study. Severe uncontrolled systemic disease. Drug dependents and alcoholics. Subjects not willing to comply with protocol requirements. Subjects with recent history of cardiovascular surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? Significant decrease in pain from baseline till the completion of therapy. Pain assessment will be done at the baseline and on day 3 and day 7 with the help of 0-10 cm VAS. ? Severity of the condition will be assessed on a 5-point rating scale of very severe, severe, moderate, and mild and none for spasm. ? A 5 point rating scale of unable, difficult, moderate, mild, and unaffected for mobility at baseline and on 3 and 5 days after treatment. Timepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| ? The overall clinical outcome of symptoms of pain, swelling spasm, tenderness, redness, spasm will be assessed on a 4-point scale of persisted, reduced, disappeared and worsened on day of study completion, i.e. on day 7. ? Efficacy and tolerability evaluation will be done independently by the patients and investigator on study completion on a 4 point rating scale of Excellent, Good, Moderate, and Poor. Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactDr. Nitin M Rathod
Outcome results
None listed