Health Condition 1: M199- Osteoarthritis, unspecified site
Conditions
Interventions
Intervention1: Flexabenz Gel: 1 inch of Gel to be applied 3-
4 times a day on the affected
area for 30 days
Control Intervention1: Volini Gel: 1 inch of Gel to be applied 3-
4 times a day on the affec
Sponsors
Dr Rahul Thakare
Biosphere Clinical Research PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients aged between 18 to 65 years of age (both ages inclusive) 2. Diagnosed with low back pain due to osteoarthritis of spine with presence of at one of the following symptoms: Pain at rest Pain at night Restriction of movement Pain on movement Stiffness Numbness Tenderness Kinesalgia 3. X-ray of lumbar spine showing evidence of OA as per Investigator discretion 4. Women of childbearing potential must be willing to consistently use an appropriate method of contraception 5. Willingness to give their written informed consent to participate in the study 6. Is willing to comply with all aspects of the protocol
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to active ingredients or inactive ingredients of the study treatment. 2. Female patients who are pregnant or lactating or planning to be pregnant. 3. Patients receiving physical therapy or heat therapy or acupuncture therapy 4. Patients with known HIV infections. 5. Patients with impaired liver function, defined as SGOT 2.0 times the upper limit of normal. 6. Patients with impaired kidney function, confirmed by serum creatinine >2.0 mg/dl. 7. Patients with presence of active peptic ulcer or any other disease affecting the absorption of drug history of gastrointestinal bleeding (hematemesis or malena). 8. Patients who have received study treatment within four weeks prior to screening. 9. History of coronary artery bypass graft within 6 months of screening. 10. Concomitant use of corticosteroids (any formulation) or use within 30 days of randomization. 11. History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses if the disease exacerbates during the study 12. History of hematologic or endocrine disorders. 13. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium or methotrexate within the past month prior to screening 14. Low back pain due to following conditions; Acute disc herniation Spondylolisthesis Ankylosing Spondylitis Infection & Malignancy 15. On clinical examination following has to be ruled out like instability problem, nerve root signs, radiculopathy and postural problem. 16. Evidence or history of clinically significant medical or surgical abnormality including clinically significant laboratory parameters that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses if the disease exacerbates during the study. 17. History of drug/substance abuse 18. Poor general condition, which in the opinion of the Investigator makes the patient ineligible to participate in the study 19. Patients who are currently enrolled in another clinical study or have been enrolled in any low back pain research study within a 30 days prior to screening. 20. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in visual analogue score from baseline on Day 31 (±2 days) in both treatment groupsTimepoint: Day 31 (±2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in visual analogue score from baseline on Day 16 (±2 days) in both treatment groupsTimepoint: Day 16 (±2 days) | — |
Countries
India
Contacts
Public ContactDr Rahul Thakare
NAMCO Charitable Trusts SGS Cancer Hospital,
Outcome results
None listed