A Clinical Study to Evaluate the Safety and Efficacy of Microscopic Doses Oral Administration of Gold Nanoparticles (AuNPs) on Knee Joint Health and Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score
研究概览
简要总结
The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving joint health, function, and quality of life for arthritis patients.
详细描述
The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving knee joint health, function, and quality of life for arthritis patients. A total of 51 participants were followed for 20 weeks through a three phase longitudinal study. Both subjective and objective parameters were used to measure and monitor changes in knee joint health and function, as well as quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Phase 1 was double-blinded, neither investigator nor participants know what products each participant was taking.
入排标准
- 年龄范围
- 18 Years 至 87 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 and <87 years of age
- •Having arthritis
- •Suffering from chronic knee pain
- •Failed treatments to date - including surgery, Physical Therapy, NSAIDs
- •Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study
排除标准
- •Having bacterial, intra-articular, or knee infections
- •Had any knee related partial or complete total knee replacement within 3 months prior to the start of the study
- •Had recent (3 months prior to start of the study) knee injection
- •Currently on NSAIDs
- •currently pregnant or lactating
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score
时间窗: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Activities of Daily Living (ADL) score
时间窗: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Leg Press repetition number
时间窗: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
C-Reactive Protein
时间窗: 20 weeks
C-Reactive Protein levels were measured at T0 for baseline scores, and then measured again at T1, T2, and T3. As CRP levels are biomarkers of systemic inflammation, it was expected to see a decrease in CRP levels when taking AuNP Supplement.
6-minute Walk distance (meter)
时间窗: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Knee injury and Osteoarthritis Outcome Score (KOOS): Symptoms score
时间窗: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Sports and Recreation score
时间窗: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Knee injury and Osteoarthritis Outcome Score (KOOS): Quality of Life score
时间窗: 20 weeks
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function \& Daily Living, Sports \& Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems.
Sit-to Stand repetition number
时间窗: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Range of Motion Bilateral Flexion score
时间窗: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
Single Leg Squats repetition number
时间窗: 20 weeks
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats.
次要结局
- Number of Event for Loss of Balance (LOB)(20 weeks)
- Movement efficiency index(20 weeks)
- Squat Lumbar Flexion Deviation score(20 weeks)
- Squat Lateral Shift Deviation score(20 weeks)
- single leg squat speed(20 weeks)
- Percentage of participants that would continue taking the product after the study ended.(20 weeks)
- single leg squat tibial inclination(20 weeks)