A Randomized double blinded comparative clinical study to evaluate the efficacy and safety of Curcumin (20 percentage SR and 95 percentage IR) in osteoarthritis and patients with low back ache.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1. Change from baseline to 8 weeks in knee and back pain intensity measured by pain VAS Scale (0 to100 mm)
研究概览
简要总结
This randomized study evaluates the efficacy and safety of Curcumin formulations in 100 patients with osteoarthritis and low back ache. Patients will receive Curcumin 20% (SR), Curcumin 95% (IR), placebo, or comparator Curcumin for 8 weeks. Outcomes include pain reduction, inflammation markers, quality of life, and safety through adverse events and lab parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria (Class III) and confirmed with X-rays and grade 3 or 4 as per Kellgren and Lawrence classification system and patients suffering from low back ache over the past 3 months.
- •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.
- •Patients, 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 and Lumbar spondylosis.
- •Uncontrolled hypertension (180/100) or Diabetes (HbA1c greater than 10)
- •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
- •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 decided as unfit for study by Clinical investigator.
结局指标
主要结局
1. Change from baseline to 8 weeks in knee and back pain intensity measured by pain VAS Scale (0 to100 mm)
时间窗: Day 0, week 4 and week 8
2. Change from baseline to 8 weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale.
时间窗: Day 0, week 4 and week 8
3. Changes from base line to 8 weeks in following laboratory parameter(s):
时间窗: Day 0, week 4 and week 8
Hs C Reactive Protein
时间窗: Day 0, week 4 and week 8
ESR
时间窗: Day 0, week 4 and week 8
4. Change in baseline to 8 weeks in Patients Global Assessment of osteoarthritis and low back ache.
时间窗: Day 0, week 4 and week 8
5. Number of patients 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: Day 0, week 4 and week 8
6. Changes from baseline to 8 weeks in Quality of life- Questionnaires (Short Form Health 12).
时间窗: Day 0, week 4 and week 8
次要结局
- To demonstrate safety and tolerability of study product by clinical AEs, including laboratory abnormalities (If any)
研究者
Dr M Sakthi Balan MBBS MD
Ki3 Private Limited