A Phase III, Open-Label, Single-Arm, Single-Centered Clinical Study To Evaluate The Safety And Efficacy Of Combination Therapy Of Boswellia Curcumin And Joint Aid Plus In Subjects With Joint Pain.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in total WOMAC score from Baseline to Day 30 ± 3, Day 60 ± 3, and Day 90 ± 3 days. WOMAC assesses pain, stiffness, and physical function. Total score: 0–96 (higher = worse symptoms). Primary efficacy is the reduction in total WOMAC score from Baseline to Day 90 ± 3 days.
研究概览
简要总结
Brief Summary and Purpose of the StudyThis clinical study is designed to evaluate the safety and effectiveness of a combination of Boswellia Curcumin and Joint Aid Plus in people suffering from joint pain due to knee osteoarthritis. Osteoarthritis is a common age-related condition that causes pain, stiffness, and difficulty in joint movement.
Both Boswellia serrata (Shallaki) and Curcuma longa (Turmeric) are known in Ayurveda for their natural anti-inflammatory and pain-relieving properties. Joint Aid Plus is a polyherbal Ayurvedic formulation containing herbs like Shallaki, Nirgundi, and Ashwagandha, which help reduce joint pain and improve flexibility.
The purpose of this study is to see how well the combination therapy works in improving pain, joint function, and overall quality of life over a period of 90 days using standard tools like WOMAC, VAS, and SF-36 questionnaires.
This is a Phase III, open-label, single-arm, single-center study involving 60 participants who will receive the investigational products for 90 days. The study will also assess the safety and tolerability of the herbal formulations through regular health checks and monitoring of any side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
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.Age between 40 and 70 years (inclusive), of either sex.
- •2.Written informed consent obtained voluntarily prior to initiation of study-related procedures.
- •3.Clinical diagnosis of unilateral or bilateral knee osteoarthritis for more than 3 months, as determined by a physician based on clinical symptoms and physical examination.
- •4.Willingness and ability to comply with all scheduled visits, treatment regimen, study procedures, and completion of questionnaires (WOMAC, VAS, SF-36).
- •5.Stable general health condition with no major planned changes to existing medications during the study period.
排除标准
- •1.History of knee or hip joint replacement surgery, or significant hip or lower back pain that interferes with ambulation or could confound study assessments.
- •2.Anticipated requirement for orthopedic surgery during the 90 days treatment period.
- •3.Pregnant or lactating women, or women planning to conceive during the study period.
- •4.Participation in another clinical trial or use of any investigational drug within 30 days prior to screening.
- •5.Uncontrolled diabetes mellitus, defined as fasting blood glucose greater than 140 mg per dL or HbA1c greater than 7.5 percentage at last available assessment.
- •6.Chronic respiratory illnesses such as chronic obstructive pulmonary disease (COPD), or history of breathing disorders that may impact physical activity tolerance.
- •7.Current or recent (within 6 months) use of immunosuppressive medications, or diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, lupus).
- •8.Known allergy or hypersensitivity to Boswellia, curcumin, or any herbal ingredients in the investigational products.
- •9.Any other medical or psychiatric condition which, in the opinion of the investigator, may compromise Subject Safety or interfere with the objectives of the study.
结局指标
主要结局
Change in total WOMAC score from Baseline to Day 30 ± 3, Day 60 ± 3, and Day 90 ± 3 days. WOMAC assesses pain, stiffness, and physical function. Total score: 0–96 (higher = worse symptoms). Primary efficacy is the reduction in total WOMAC score from Baseline to Day 90 ± 3 days.
时间窗: Day 0, Day 30 ±3 days, Day 60 ±3 days, Day 90 ±3 days
次要结局
- 1.Change in Visual Analogue Scale (VAS) Score for Joint Pain(2.Change in Quality of Life Score as measured by SF-36 from Baseline to Day 90)
研究者
Dr BN Satish
RVS Ayurvedic Medical College Hospital and Research Centre