CTRI/2020/04/024588尚未招募4 期
A Prospective, Single-center, Open label, Randomized,Parallel-group, Active-controlled Clinical Study to Evaluate the Efficacy and Safety of Flexabenz Gel versus Volini Gel in the treatment of Patients with Low Back Pain due to Osteoarthritis of Lumbar Spine
Dr Rahul Thakare0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •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
- •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
排除标准
- •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
- •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.
研究者
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