A Clinical Study to evaluate the effect and safety of Flexabenz Gel versus Volini Gel in the treatment of Patients with Low Back Pain due to Osteoarthritis of Lumbar Spine
- Conditions
- Health Condition 1: M199- Osteoarthritis, unspecified site
- Registration Number
- CTRI/2020/04/024588
- Lead Sponsor
- Dr Rahul Thakare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in visual analogue score from baseline on Day 31 (±2 days) in both treatment <br/ ><br>groupsTimepoint: Day 31 (±2 days)
- Secondary Outcome Measures
Name Time Method Change in visual analogue score from baseline on Day 16 (±2 days) in both treatment <br/ ><br>groupsTimepoint: Day 16 (±2 days)