A Randomized, Open label, Clinical study to evaluate the efficacy and safety of Amrutanjan Advanced Ortho Pain Relief + Oil in osteoarthritis and Rheumatoid arthritis patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Knee pain intensity measured by Pain VAS Scale ( 0- 100mm)
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 60 participants with Osteoarthritis and Rheumatoid arthritis will be enrolled in this study in two separate arms.
The IP will be applied on the affected area three times a day for 8 weeks.
The following parameters will be monitored.
Primary end Points
1. 1. Knee pain intensity measured by Pain VAS Scale (0 to 100 mm)
2. 2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, Physical Function and Stiffness Subscale.
3. 3. Changes in following laboratory parameter(s) for all the patients: C Reactive Protein and ESR
Change from base line to week 8 in the RA factor for RA patients.
4. 4. Patients Global Assessment of Osteoarthritis or Rheumatoid arthritis patients.
5. 5. Number of Participants with a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT OARSI).
6. 6. Quality of life Questionnaires using Short Form Health 12.
7. 7. X ray (knee joint) will be done at Baseline and at end of 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 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 with grade I and II as per Kellgren and Lawrence classification system and patients previously diagnosed with Rheumatoid arthritis (grade I and II) as per the American Rheumatism Association.
- •Have been on stable dose of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS) and other treatments for a minimum period of 3 months in the past.
- •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
- •Recent history of trauma to the knee joint.
- •Having severe pain and inflammation, which is not getting controlled on NSAIDs
- •Uncontrolled diabetic patients with Hba1C greater than
- •Pregnant or lactating
- •Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity
- •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 (like instability of knee joint, ligament tear or loose bodies in knee joint) decided as unfit for study by Clinical investigator.
结局指标
主要结局
1. Knee pain intensity measured by Pain VAS Scale ( 0- 100mm)
时间窗: Week 2, 4, 6 and 8
2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, Physical Function and Stiffness Subscale.
时间窗: Week 2, 4, 6 and 8
3. Changes in following laboratory parameters for all the patients: C Reactive Protein and ESR
时间窗: Week 2, 4, 6 and 8
Change from base line to week 8 in the RA factor for RA patients.
时间窗: Week 2, 4, 6 and 8
4. Patients Global Assessment of Osteoarthritis or Rheumatoid arthritis patients.
时间窗: Week 2, 4, 6 and 8
5. Number of Participants with a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT OARSI).
时间窗: Week 2, 4, 6 and 8
6. Quality of life Questionnaires using Short Form Health 12.
时间窗: Week 2, 4, 6 and 8
7. X ray (knee joint) will be done at Baseline and at end of 8 weeks.
时间窗: Week 2, 4, 6 and 8
次要结局
- Safety and tolerability evaluation criteria:(Adverse events and serious adverse events during the study period)
研究者
Dr M Sakthi Balan MD
Ki3 Pvt Ltd