CTRI/2023/11/060117已完成Phase 3 4
A double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 20% Turmeric Extract in patients with Joint pain of the knees
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1 Mean change in KOOS score
研究概览
简要总结
The study involves 60 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 20% turmeric extract500mg or Placebo (Microcrystalline cellulose-500mg) Arm-2. Specific biomarkers such as IL-6, HsCRP, ESR 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 and Outcome Assessor 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 ≥30 and ≤ 65 years.
- •Participants must provide a written and signed informed consent and comply with requirements of the study.
- •Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.
- •HsCRP level ≥ 3mg/L.
- •Patient with mild to moderate pain in knees.
- •Patients with morning stiffness, painful joint movement and not on any anti-inflammatory medications.
- •Patients with the pain perception ranging from 30 to 60 based on VAS (Visual Analog Scale) of 0 – 100mm.
排除标准
- •Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection.
- •Patients with a history of knee or hip replacement surgery.
- •Treatment of knee joint pain with intra-articular injection of corticosteroids within the last 3 months preceding study.
- •Patients suffering from any other chronic diseases like uncontrolled diabetes, hypertension, liver disorders, cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor.
- •Patient with history of Asthma or on medication with Ipratropium Bromide.
- •Patients undergoing treatment for any other systemic illness.
- •Medication: i.
- •Participants who have used the following substances within 1 week prior to screening – glucosamine sulfate, chondroitin sulfate, NSAID, glucocorticoids, or steroids.
- •Participant who have used hyaluronate within a month prior to screening.
- •Participants who have used any of the below dietary supplements within the past 30 days – Boswellia, Omega3, Collagen, Curcumin etc
- •History of chronic smoking and Alcoholics.
- •Those who have participated in any other clinical trial within the last 3 months from the date of visit 1 or who plan to participate in any other study during the clinical trial period.
- •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 KOOS score
时间窗: 1 Randomisation Day to Day 90 | 2 Screening Day to Day 90
2 Mean change in VAS Pain Scale
时间窗: 1 Randomisation Day to Day 90 | 2 Screening Day to Day 90
次要结局
- 1 Mean change in the HsCRP(2 Mean change in IL-6)
研究者
研究点 (2)
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