A case study to evaluate the efficacy and safety of Collashot C2 Plus inosteoarthritis patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. VAS pain score
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.30 Participants will be randomized into single group. Dosing will be done daily orally for 12 weeks. Subjects will be asked to visit clinical facility/institution for their followup at the end of week 4, week 8 and week 12 and any other additional visits if needed.
Primary and Secondary Outcome
1)McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
-
Pain VAS Scale
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Hs-C Reactive Protein
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ESR and C Telopeptide
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Patient’s Global Assessment of Osteoarthritis
-
Number of Participants with a response rate measured by the Outome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)
-
Quality Life Questionnaires
-
XRay-Pre and Post
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
- •Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria and confirmed with X-rays and ACR functional class of III and with grade 3 or 4 as per Kellgren and Lawrence classification system.
- •Have been on stable dose of prescription Nonsteroidal Anti- Inflammatory Drugs (NSAIDS), or acetaminophen of at least 2000 mg per day for at least 20 days in the past month.
- •Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS)
- •Patient should have not participated in any other clinical trial during the past 3 months.
- •Participants, who are willing to give written, signed and dated informed consent to participate in the study.
排除标准
- •Arthritis of the knee from other causes
- •Uncontrolled hypertension or diabetes
- •Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra- articular injections, duloxetine, or venlafaxine
- •Moderate to severe renal impairment
- •Pregnant or lactating
- •Suffering from any illness which will interfere with present study as decided by clinical investigator
- •History of hypersensitivity to any of the test products.
- •Any condition decided as unfit for study by clinical investigator.
结局指标
主要结局
1. VAS pain score
时间窗: Day 0 and Week 12
2. WOMAC scoring
时间窗: Day 0 and Week 12
3. ESR, CRP and C-telopepetide
时间窗: Day 0 and Week 12
4. OMERACT-OARSI
时间窗: Day 0 and Week 12
5. Quality of life
时间窗: Day 0 and Week 12
次要结局
- To demonstrate safety and tolerability of study product by clinical AEs,(including laboratory abnormalities (If any))