Health Condition 1: null- Symptomatic with acute low back pain, with or without radiating pain no lower than the knee, for less than 3 days.
Conditions
Interventions
Intervention1: Novigan MR: Ibuprofen + Chlorzoxazone tablets (400mg+500mg)
Route of Administration - Oral
Frequency - 3 times daily
Control Intervention1: Brufen 400: Ibuprofen tablets 400mg
Route
Sponsors
Dr Reddys Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient of either sex between 18 to 60 years of age 2. Symptomatic with acute low back pain, with or without radiating pain no lower than the knee, for less than 3 days 3. Patients willing to take the medications as directed and willing to come for the follow-ups 4. Willing to comply with the protocol requirements 5. Willing to give the written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients associated with other lumbar or cervical spinal tract conditions such as spondylitis, fracture, cancers, severe arthritis and osteoporosis. 2. Muscular diseases such as myositis, poliomyositis, muscular dystrophy and myotonia. 3. Other known systemic diseases affecting the neurological or endocrine system. 4. Patients with moderate to severe hepatic impairment (defined as increase in serum bilirubin, SGOT & SGPT by >2.5 times the upper reference level of the laboratory values) and renal impairment (defined as increase in serum creatinine and Blood urea nitrogen by >2.5 times the upper reference level of the laboratory values). 5. Patients who had taken any form of skeletal muscle relaxant in the previous 48 hours (2 days). 6. Pregnant / Lactating Woman or women of child bearing potential not following adequate contraceptive measures. 7. Patients with known hypersensitivity to ingredients of study/active comparators. 8. Patients with any previous H/O or current episode of cardiovascular disorders. 9. Subject known to be having any of the following disorder: Renal failure, Bulimia, Hypo and hyperthyroidism, Nephrotic Syndrome, Anorexia nervosa, biliary obstruction, severe cardiac dysfunction. 10. Uncontrolled diabetes mellitus or any other metabolic disorder. 11. Patients with H/O alcohol of substance abuse. 12. Treatment with any investigational drug in the preceding 4 weeks. 13. Patients with active or recent history of, inflammatory diseases of the gastrointestinal tract such as peptic ulcer, gastritis, regional enteritis, or ulcerative colitis. 14. Patients in whom Acetyl Salicylic Acid (ASA) or other nonsteroidal anti-inflammatory agents (NSAIDs) have induced asthma, rhinitis, urticaria or other allergic manifestations. 15. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in pain in the affected region (back and legs) assessed on a 0 â?? 100 mm Visual Analogue Scale (VAS) at 3 days post-initiation of treatment measured 2 hours after consumption of the morning dose.Timepoint: 3rd and 7th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Summed Pain Intensity Difference (SPID) after 24 hours of study treatment measured 2 hours after drug administration (SPID-01) 2. SPID after 3 days of study treatment measured 2 hours after drug administration (SPID-03) 3. SPID after 7 days of study treatment measured 2 hours after drug administration (SPID-07) 4. Total Pain Relief (TOTPAR) scores up to 3-hour post-dosing measured hourly. Pain Relief Rating (PRR) will be assessed on a 5-point categorical scale wherein:Timepoint: 3rd and 7th day | — |
Countries
India
Contacts
Public ContactMr Ritesh Khandewlal
Dr Reddys Laboratories Pvt. Ltd.
Outcome results
None listed