Effectiveness of a Herbal Supplement Containing Boswellia Serrata, Curcuma Longa, and Vitis Vinifera in Patients With Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
研究概览
简要总结
This study aims to evaluate the effectiveness and safety of a combined herbal supplement containing Boswellia serrata, Curcuma longa, and Vitis vinifera in adults with clinically diagnosed knee or hip osteoarthritis.
The primary objective is to determine whether the supplement improves osteoarthritis-related symptoms.
The supplement will be compared with a placebo.
Participants will:
- take the supplement and placebo for 4 weeks each, one at a time;
- complete validated questionnaires (6 times online)
- perform three performance-based physical tests (6 times online)
- provide a urine sample
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18
- •Diagnosis of osteoarthritis in knee or hip
- •Numerical Rating Scale (NRS) ≥ 4 during the most painful movement in the last 24 hours
- •Lequesne's Functional Index (LFI) score ≥ 7
- •Ambulant patient
排除标准
- •Pregnant and breastfeeding
- •Autoimmune disease such as rheumatoid arthritis, gout, lupus
- •Joint trauma, joint injury, joint infection, meniscus tear, complete loss of articular cartilage
- •Expectation of surgery
- •History of the viscous or corticosteroids injections into affected joints or oral corticosteroids within last 12 months
- •Allergy to one of the intervention's ingredients or NSAIDs
- •Peptic ulceration and upper gastrointestinal haemorrhage
- •High alcohol intake, inability to abstain from alcohol, substance abuse, history of addiction
- •Tumor, cancer
- •Abnormal renal or/and hepatic functions or altered blood chemistry
- •Use of concomitant medication able to interfere with the interventions
研究组 & 干预措施
Active Treatment
Dietary supplement containing standardised herbal extracts of Boswellia Serrata (525 mg), Curcuma Longa (150 mg), Vitis vinifera (75 mg)
干预措施: Active treatment (Dietary Supplement)
Placebo
Dietary supplement placebo containing no standardised herbal extracts or other active ingredients.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
时间窗: Change from the start of the intervention to Week 4 of supplementation
Western Ontario and McMaster Universities Arthritis Index, a validated, specialised instrument used to assess pain, stiffness, and physical function in people with osteoarthritis. Scores range from 0 to 96 (Likert version), with higher scores indicating worse pain (0-20), stiffness (0-8), and physical function (0-68).
Change in Numeric Rating Scale (NRS) score
时间窗: Change from the start of the intervention to Week 4 of supplementation
Numeric Rating Scale. A specialised pain assessment tool, where patients rate their pain intensity on a scale from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate worse outcomes.
Change in Intermittent and Constant Osteoarthritis Pain knee/hip (ICOAP) score
时间窗: Change from the start of the intervention to Week 4 of supplementation
ICOAP. A Measure of Intermittent and Constant Osteoarthritis Pain knee/hip To assess two distinct types of pain experienced by people with osteoarthritis-intermittent pain (comes and goes, 0 - 24) and constant pain (persistent, ongoing pain, 0 - 20). Scores range from 0 to 44, with higher scores indicating more severe osteoarthritis related pain.
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) score
时间窗: Change from the start of the intervention to Week 4 of supplementation
EuroQol 5-Dimension 5-Level questionnaire. A generic, widely used tool to measure health-related quality of life. It measures five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. A score of 1 indicates no problems, while 5 indicates extreme problems in the respective dimension. In addition, the EQ Visual Analogue Scale (EQ-VAS) records the respondent's self-rated health on a vertical scale ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Change in urinary C-terminal telopeptide of type II collagen (uCTX-II) levels
时间窗: Change from the start of the intervention to Week 4 of supplementation
uCTX-II (urinary C-terminal telopeptide of type II collagen) is a biochemical marker measured in urine that reflects type II collagen degradation, which occurs primarily in articular cartilage.
次要结局
- Evaluation of Minimal Clinically Important Difference for measured scores(Change from the start of the intervention to Week 4 of supplementation)
- Change in 30-Second Chair Stand Test(Change from the start of the intervention to Week 4 of supplementation)
- Change in Stair Climb Test(Change from the start of the intervention to Week 4 of supplementation)
- Change in 40-metre Fast-Paced Walk Test(Change from baseline to the end of Week 1 of supplementation)
- Change in the 40-metre Fast-Paced Walk Test (4 × 10 m)(Change from the start of the intervention to Week 4 of supplementation)
- Global Physical Activity Questionnaire(Change from the start of the intervention to Week 4 of supplementation)
- Adverse events(The length of intervention: 4 weeks)
- Rescue medication(The length of intervention: 4 weeks)
- Change in 30-Second Chair Stand Test(Change from baseline to the end of Week 1 of supplementation)
- Change in Stair Climb Test(Change from baseline to the end of Week 1 of supplementation)
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) score.(Change from baseline to the end of Week 1 of supplementation)
- Change in Numeric Rating Scale (NRS) score(Change from baseline to the end of Week 1 of supplementation)
- Change in Intermittent and Constant Osteoarthritis Pain knee/hip (ICOAP) score(Change from baseline to the end of Week 1 of supplementation)
- Change in Lequesne Functional Index (LFI) score(Change from baseline to the end of Week 1 of supplementation)
- Change in Lequesne Functional Index (LFI) score(Change from the start of the intervention to Week 4 of supplementation)
研究者
Patrycja Brodka Pedro
PhD Student in Biomedicine, Bioscience Laboratory Technician
Middlesex University