前言 : 今天上班累啊,無腦抓重點節錄了
Investigational product :
40mg的UC-II(內含10.4 ± 1.3mg自然的二型膠原蛋白)和excipient(microcrystalline cellulose、magnesium stearate和silicon dioxide)包覆在不透明膠囊中,安慰劑為單純的excipient。研究材料皆由合格的GMP藥廠InterHealth Nutraceuticals,Inc所提供
Recruitment of subjects :
One hundred and six subjects were screened for eligibility using the inclusion–exclusion criteria defined in Table. Only healthy adults who presented with no knee joint pain at rest and no diagnosable markers indicative of active arthritic disease, as outlined by the American College of Rheumatology (ACR) guidelines, were admitted into the study. To accomplish this, all potential subjects were screened by a board certified clinician. Subjects presenting with any knee pain at rest and at least 3 of 6 clinical classification criteria, which included age greater than 50 years, morning stiffness in the joint lasting 30 minutes or less, crepitus on knee joint manipulation, body tenderness, bony enlargements, knee swelling or presence of excess fluid, and palpable warmth, were excluded. Potential subjects reporting the occasional use of NSAIDs, other pain relief medication, or anti-inflammatory supplements underwent a 2-week washout period before randomization.
Study schedule :
The study duration was 17 weeks with a total of 7 visits that included screening, baseline, days 7, 30, 60, 90 and 120 (final visit) summarizes the study visits and activities. it depicts the sequence of study procedures that subjects underwent during each visit. All subjects completed a medical history questionnaire at baseline and compliance reports during follow-up evaluations at 7, 30, 60, 90 and 120 days. Subjects were assessed for anthropometric measures, vital signs, knee range of motion (flexion and extension), six-minute timed walk, as well as the onset and recovery from pain using the Udani Stepmill Procedure. A Fitbit (San Francisco, CA) device was used to measure daily distance walked, steps taken and an average step length for study participants. Subjects were also asked to complete the KOOS survey as well as the Stanford exercise scales.
全程實驗長度17周,第7天、第30天、第60天和第120天,探訪時監測的項目有vital sign、膝蓋活動範圍、六次行走、
Conclusion :
At study conclusion, we found that subjects ingesting the UC-II supplement experienced a significantly greater forward ROM in their knees versus baseline and placebo as measured by knee extension goniometry. Knee extension is necessary for daily function and sport activities. Loss of knee extension has been shown to negatively impact the function of the lower extremity. For example, loss of knee extension can cause altered gait patterns affecting ankles and the hip which could result in difficulty with running and jumping. Studies have further shown that a permanent loss of 3-5º of extension can significantly impact patient satisfaction and the development of early arthritis.
By contrast, when knee flexion, another measure of knee function, was assessed via goniometry, no differences in clinical outcomes were observed between the two study cohorts. From a structure-function perspective this outcome is not surprising. During the earliest characterized phases of OA there is an apparent preferential loss of knee extension over knee flexion, and this loss has been shown to correlate with WOMAC pain scores
UC-II在改善knee extension方面較有相當的療效,而在knee flexion就沒有顯著的效果了
Referrence :