Double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of C3 Reduct in patients with Joint Inflammation of the knees.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- 1. Mean change in the KOOS & modified WOMAC score for pain, stiffness and function sub-scale.
研究概览
简要总结
The study involves 96 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow-up after 7 days following the last visit. Participants will be randomized to receive either C3 reduct-70mg (Arm-1) or Placebo (Microcrystalline cellulose-70) Arm-2. Specific biomarkers such as IL-6, HsCRP, lipid Profile will be measured and analysed during the study period. Goniometer and scales such as modified WOMAC and KOOS will be also analysed during the study period. The final statistical analysis and study report will be complied at the end of the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female participants whose age ≥18 and ≤ 60 years.
- •Participants should provide a written and signed informed consent and comply with requirements of the study.
- •HsCRP level should be equal or more than 3 mg/dl.
- •Patients with morning stiffness, painful joint movement and not on any anti-inflammatory medications.
- •Patients with the pain perception ranging from 30 to 100 when measuring VAS (Visual Analog Scale) of 0- 100mm.
- •Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.
排除标准
- •Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infections.
- •Patients with history of knee and hip replacement surgery.
- •Treatment of knee joint pain with intra-articular injections of corticosteroids within last 3 months preceding study.
- •Patients suffering from any other chronic diseases like uncontrolled diabetes, hypertension, liver disorders, cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease or malignant tumour.
- •Patients with history of asthma or on medication with Ipratropium Bromide.
- •Patients undergoing treatment for any systemic illness.
- •Pregnant, lactating women or women of childbearing potential and those who are not willing to follow a reliable and effective contraceptive measure during the study.
- •History of chronic smoking and alcoholics.
- •Those who have participated in any other clinical trial within the last 3months from the date of first visit.
- •Any other condition/ reason which the principal investigator thinks may jeopardize the study.
结局指标
主要结局
1. Mean change in the KOOS & modified WOMAC score for pain, stiffness and function sub-scale.
时间窗: 1. Mean change in the KOOS & modified WOMAC score for pain, stiffness and function sub-scale from day-1 to day 90. | 2. Mean change in the VAS from screening to day 90.
2. Mean change in the VAS
时间窗: 1. Mean change in the KOOS & modified WOMAC score for pain, stiffness and function sub-scale from day-1 to day 90. | 2. Mean change in the VAS from screening to day 90.
次要结局
- 1. Mean change in the HsCRP, IL-6 & ESR.(2. Mean change in the range of Movement by Goniometer.)