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临床试验/NCT03636035
NCT03636035已完成不适用

Assessment of Performance of Participants With Mild Knee Osteoarthritis Taking Tregocel® as a Dietary Supplement Alongside Standard of Care Treatment

Max Biocare Pty. Ltd.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年1月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Change in distance walked in 6-minutes as an indicator of AMBULATORY MOBILITY
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is an assessment of the overall performance of participants with symptomatic mild knee OA taking Tregocel® as a dietary supplement in addition to standard of care treatment.

详细描述

Tregocel® is a combination herbal product which as a dietary supplementation may help maintain proper performance of joints. Although some studies have reported beneficial effects for individual components of Tregocel®, there have been no clinical assessments of supplementation with Tregocel® as a finished product. This study will involve collection of data on Tregocel® supplementation in participants with symptomatic mild knee osteoarthritis (OA) who are already receiving standard pharmacological treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Compliance with all study procedures
  • •Fulfilment of consent process
  • •Documented diagnosis of radiologically confirmed mild knee osteoarthritis with stable pain management (including patello-femoral joint, Kellgren-Lawrence classification ≤2 and clinical symptoms lasting more than 6 months prior to screening)
  • •Maximal pain score ≥30 on a 100 mm VAS at screening and confirmed at baseline, with PRN use of analgesics during run-in
  • •Completed patient diary during run-in
  • •Ambulant with ECOG score <2

排除标准

  • •pregnancy or breastfeeding (women)
  • •body mass index less than 18.5 kg/m^2 or more than 35.0 kg/m^
  • •secondary knee OA
  • •clinically apparent tense effusion of the target knee
  • •valgus/varus knee/foot deformities, ligament laxity, or meniscal instability
  • •changes in regular OA therapy during screening
  • •chronic diseases which may require treatment with systemic steroids
  • •progressive serious medical conditions
  • •severe organ dysfunction
  • •cardiac insufficiency
  • •history of gastrointestinal ulcer or bleeding.
  • •any significant medical conditions that may interfere with the study procedures, safety, compliance or overall participation in the study
  • •allergies or intolerance to any of the dietary supplement ingredients

结局指标

主要结局

Change in distance walked in 6-minutes as an indicator of AMBULATORY MOBILITY

时间窗: Tested at Baseline (week 0) and at end of supplementation (week 36)

Challenge involves subject walking unimpeded along a continuous straight line of 30 metre in distance with no incline. Distance covered will by an assistant sured with a 30 metre metric tape measure. Laps and time will be tracked manually with a digital lap counter and timer (second). Baseline values will be compared to values after supplementation to determine any change in individual performance.

次要结局

  • Physical exam parameter 2: SUBJECT HEIGHT measurement(Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Vital sign 2: BLOOD PRESSURE(Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Arthritis self-assessment 2: change in degree of PERCEIVED PAIN represented by manual marking on a printed 100mm linear scale (During and after supplementation) in response to WOMAC questionnaire(Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Arthritis self-assessment 3: change in degree of PERCEIVED STIFFNESS represented by manual marking on a printed 100mm linear scale (During and after supplementation) in response to WOMAC questionnaire.(Scores taken at baseline (0 week); rescored at 12, 24, 36 and 40 weeks)
  • Arthritis self-assessment 1: Initial degree of PERCEIVED PAIN represented by manual marking on a simplified printed 100mm linear scale (during Run-in)(Run-in period (week -1 to week 0))
  • Safety assessment 1: clinical HEMATOLOGY parameters (c) sodium level(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (d) potassium level(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (g) total bilirubin level(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (h) alkaline phosphatase level(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Physical exam parameter 1: BODY WEIGHT measurement(Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Vital sign 1: BODY TEMPERATURE(Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Arthritis self-assessment 4: change in degree of PERCEIVED DIFFICULTY WITH DAILY TASKS represented by manual marking on a printed 100mm linear scale (During and after supplementation) in response to WOMAC questionnaire.(Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Change in target KNEE FLEXIBILITY assessment, based on heel-thigh distance and knee angle at maximal flexion.(Scores taken supine and prone for both knees at baseline (week 0); rescored at 12, 24, 36 weeks)
  • Safety assessment 2: URINALYSIS (a) presence of leukocytes(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (j) glucose level(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Determination of total usage of PRESCRIPTION ANALGESICS(Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Vital sign 3: PULSE RATE(Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (e) aspartate alanine transferase level(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (i) creatine level(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (j) blood sodium(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (c) level of urobilinogen(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (d) presence of protein(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (e) pH(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (f) presence of blood(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (a) Blood cell count(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (f) alanine aminotransferase(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (b) hemoglobin level(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (g) specific gravity (SG)(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (h) ketone level(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (k) presence of human chorionic gonadotrophin (hCG)(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 1: clinical HEMATOLOGY parameters (k) blood potassium(Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (b) presence of nitrites(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)
  • Safety assessment 2: URINALYSIS (i) presence of bilirubin(Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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