A Randomized Open-Label Interventional Clinical Study to Evaluate the Safety andEfficacy of PeaNoc XL tablets on arthritis patients with joint pain and inflammation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- before and after the study.
研究概览
简要总结
PeaNoc XL Tablet has been used for the treatment of pain, inflammation, etc. Hence it canbe given as add on supplement with the standard drug to improve the treatment efficacy inthe treatment of pain and inflammation in patients with arthritis.To test our hypothesis, we are attempting to conduct Clinical trial to evaluate the safetyand efficacy of PeaNoc XL tablets on arthritis patients with joint pain and inflammation bycomparing standard and treatment group
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with DAS 28 (Disease Activity Score) score greater than or equal to 3.2 -Willingness to provide written informed consent to participate in the study.
- •Patients understanding the nature and purpose of the study and who are willing to comply with study procedures.
排除标准
- •Patients who are taking other NSAID /Pain killers other than standard drug -Abnormal results on Liver function test -Patients with diabetic neuropathy -Patients with severe renal, hepatic, cardiac, gastrointestinal, neurological, hematological or respiratory disorder.
结局指标
主要结局
before and after the study.
时间窗: 06 months
1. Hematological investigations: Complete Blood count will be assessed before and after
时间窗: 06 months
3. Inflammatory cytokines (IL-1, IL-6, and TNF-α), C - reactive protein (CRP) and
时间窗: 06 months
the study.
时间窗: 06 months
2. Biochemical investigations: Serum creatinine, Liver function tests will be assessed
时间窗: 06 months
Erythrocyte sedimentation rate (ESR) will be assessed before and after the study.
时间窗: 06 months
4. DAS 28 score will be assessed before and after the study.
时间窗: 06 months
次要结局
- To assess adverse drug reactions during the study period