CTRI/2024/06/068625尚未招募Phase 3 4
A Prospective, Randomized, Double-Blind, Parallel Group, Three Arm, Study to Evaluate the Effectiveness and Safety of Green-Lipped Mussel Oil (GLMO) on Joint Health in Older Adults.
Great HealthWorks, Inc.2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年6月18日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Mean Change in questionnaire based assessments, scale and performance evaluation
研究概览
简要总结
This is a double blind, randomized (1:1:1), controlled, parallel group, three arm study. Adult individuals meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. During recruitment, assessments will be performed for patient selection as a means of standardizing the extent of pain and immobility. After confirmation of the eligibility criteria, subjects will be randomized into one of the three treatment arms. The treatment duration will be 84 days. The efficiency of supplementation on the subject’s OA symptoms will be evaluated. Efficacy assessments will be done during all the site visits. The subjects will be contacted to obtain the details of analgesic use and complete the symptom assessment questionnaires.
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
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject with Osteoarthritis (OA) (Class I-III), according to Kellgren and Lawrence system and confirmed by X-ray, who have been completely withdrawn from their previous analgesics or anti-inflammatory medications or have been newly diagnosed with mild to moderate OA, and who are not currently taking any analgesics or anti-inflammatory medications 2.Subjects with a body mass index (BMI) ≤ 29.9 kg/m2 3.Subjects willing to and able to perform the treadmill walking test 4.Subject willing to and able to complete the questionnaires required for the study 5.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 6.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
排除标准
- •Subjects with any history of fracture involving the study joint or with any other type of arthritis or OA secondary to a known disorder such as rheumatoid arthritis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, and psoriasis.
- •Subjects who had surgery, or arthroscopy within three months prior to inclusion
- •Subjects with severe bone or joint deformation or condition
- •Subjects who have been administered hyaluronic acid injections within six months prior to screening and glucosamine and/or chondroitin containing compounds within seven days prior to the screening visit
- •Subjects who have used medications with MMP-inhibitory properties or took corticosteroids within 28 days of Screening Visit.
- •Subjects with history of Any chronic health condition,Psychiatric illness, Drug abuse, smoking, abuse or addiction to alcohol, Bariatric surgery or eating disorder such as bulimia or binge eating, Cardiovascular surgery, History of any other major surgery
- •Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment
- •Subjects who have experienced a known stressful event within the last 6 months such as death in family, accident, hospitalization
- •Subjects with a known allergy to herbal products
- •Subjects who are pregnant or lactating or nursing
- •Known HIV or Hepatitis B positive or any other immuno-compromised state
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
结局指标
主要结局
Mean Change in questionnaire based assessments, scale and performance evaluation
时间窗: Day 0, Day 2, Day 28, Day 30,Day 56, Day 58, Day 84, Day 86
次要结局
- Change in biomarker levels(Day 0, Day 28, Day 56, Day 84)
研究者
Dr Raju KP
BGS Global Institute of Medical Sciences
研究点 (2)
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