CTRI/2020/03/024039尚未招募4 期
A Prospective, Single-center, Open label, Randomized, Parallel-group, Comparative Clinical Study to Evaluate the Efficacy and Safety of FDC of Trypsin + Bromelain + Rutoside trihydrate versus FDC of Glucosamine sulphate + Chondroitin sulfate and Collagen peptide in the Treatment of Patients with Osteoarthritis
Dr Aniket Nitinkumar Shah0 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. Male or non-pregnant female aged more than or equal to 35 years
- •2. Clinical diagnosis of OA knee according to the American College of Rheumatology (ACR) criteria; including Knee pain and at least three of following criteria prior to screening:
- •- Age more than 50 years
- •- Morning stiffness less than 30 minutes
- •- Crepitus on active motion
- •- Bony tenderness
- •- Bony enlargement
- •- No palpable warmth of synovium
- •3. Symptoms in knee for at least 6 months prior to screening
- •4. Knee pain for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.)
- •5. Had an X-ray of knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence Grade 1-3 disease
- •6. Ability to replace all current pain medications with paracetamol for use as needed throughout the study (patients should be able to withhold rescue medication (paracetamol) use for at least 24 hours prior to VAS pain score assessment at study visits)
- •7. If female and of child-bearing potential, must be willing to consistently use appropriate method of contraception throughout the study
- •8. Willing to comply with all aspects of study protocol
- •9. Willing to provide written informed consent for the trial
排除标准
- •1. Patients with known hypersensitivity to active ingredients or inactive ingredients of the study treatment.
- •2. Patients with known HIV infections.
- •3. Concomitant use of corticosteroids (any formulation) or use within 30 days of randomization.
- •4. Patients with impaired liver function, defined as SGOT 2.0 times the upper limit of normal.
- •5. Patients with impaired kidney function, confirmed by serum creatinine >2.0 mg/dl.
- •6. Patients with presence of active peptic ulcer or any other disease affecting the absorption of drug history of gastrointestinal bleeding (hematemesis or malena).
- •7. Patients with inflammatory arthritis and other types of arthritis
- •8. Patients with diabetes mellitus
- •9. Patients who have history of recent knee injury
- •10. Patients suffering from hematologic or endocrine disorders.
- •11. On clinical examination following has to be ruled out like instability problem, nerve root signs, radiculopathy and postural problem.
- •12. Female patients who are pregnant or lactating or planning to be pregnant.
- •13. History of drug/substance abuse
- •14. History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis, chronic inflammatory disease (e.g. colitis) or fibromyalgia
- •15. Receiving physical therapy for current condition of osteoarthritis of knee.
- •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. 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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