A randomized, double-blind, placebo-controlled clinical trial validating the effectiveness of Tendoease tablet in the rehabilitation of tendonitis.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- 2. Changesin echo texture, thickness, tendon sheath, paratenon, vascularity,
研究概览
简要总结
Tendonitis, a common form of tendinopathy, results from acute tendon injury accompanied by inflammation and reduced function, often caused by overloading the tendon. It can progress to tendinosis, a degenerative condition, if not properly managed. Risk factors include age, sudden changes in activity levels, medications, and comorbidities like diabetes and obesity. Treatment options range from physical therapies to pharmacological interventions, with emerging interest in nutraceutical supplementation. Nutraceuticals, when combined with conventional treatments, offer promise in managing tendonitis by potentially reducing pain and improving function. The rationale for investigating Tendoease tablet supplementation lies in its potential to enhance tendon rehabilitation outcomes, contributing valuable insights into multidisciplinary approaches for tendonitis management. This study aims to evaluate the safety and effectiveness of Tendoease tablets as an oral supplement, highlighting their role in enhancing tendonitis rehabilitation protocols.
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
- 16.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects meeting all of the following criteria will be eligible for the study:
- •Male and female subjects aged between 16-50 years (both inclusive);
- •Subjects with clinical or ultrasound-confirmed Achilles tendonitis, lateral epicondylitis or patellar tendonitis;
- •Subject with relapse cases of tendinosis;
- •Subjects with or without comorbidities, if comorbidity exists should be on stable prescription for more than three months;
- •Willing to provide consent and willingness for follow-up.
排除标准
- •Subjects meeting any of the following criteria will not be eligible for the study:
- •Preoperative shoulder fracture, irreparable tendon tear (Exceeding 50%), calcifying tendinitis, shoulder instability, acromioclavicular joint disorder, infection, neoplasm, symptomatic cervical spine disease, rheumatoid arthritis or immune disease, gout or uric acid disease;
- •Subjects allergic to the investigational product ingredients;
- •Subjects with any acute illness requiring immediate medical care;
- •Subjects with uncontrolled diabetes/ complicated cardiovascular diseases/ history of TIA, cerebrovascular accident, stroke or any revascularization;
- •Known subjects of hepatic or renal impairments;
- •Pregnant, breastfeeding or planning to become pregnant during the study;
- •Any other condition which proves subject unfit for the study participation.
结局指标
主要结局
2. Changesin echo texture, thickness, tendon sheath, paratenon, vascularity,
时间窗: Screening to end of | the study
The primary endpoints of the study will be to assess:
时间窗: Screening to end of | the study
1. Changes in pain score on 0-10 visual analog scale (VAS).
时间窗: Screening to end of | the study
and tendon movement by radiological investigations.
时间窗: Screening to end of | the study
次要结局
- The secondary endpoints of the study will be to assess:(1. Changes in inflammatory markers like IL-6, TNF-alpha, procollagen type)
研究者
Dr Amitava Narayan Mukherjee
Orthopaedic and Joint Replacement Clinic