Chung Shan Medical University
Taichung, Taiwan
NCT Number: NCT06658821
This project is to conduct a clinical trial of SYNBIO TECH INC.'s LDL557 capsule for joint protection. To understand the improvement of joint discomfort and inflammation after supplementation, we hope to provide an updated choice for modern people's joint protection.
Interested in participating?
Request Info45 year–80 year
All sexes
Interventional
Not applicable
Taichung, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will take once a day during the experimental period. one LDL557-HK capsule(Heat-killed Lactobacillus delbrueckii subsp. lactis LDL557 1x10^10cell) within 30 minutes before lunch.
Subjects will take once a day during the experimental period. one placebo capsule within 30 minutes before lunch.
Time frame: Baseline, Week 4, Week 8, and Week 12
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.
Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Time frame: Baseline, Week 4, Week 8, and Week 12
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire for patients with knee injuries or osteoarthritis. It helps measure their pain, symptoms, daily activities, sports ability, and quality of life. The scores are converted to 0-100 for each category. A higher score means worse knee problems.
Time frame: Baseline, Week 4, Week 8, and Week 12
The Lequesne's Index is a questionnaire designed to evaluate the severity of osteoarthritis in the hip or knee. It assesses pain or discomfort during activities, the ability to walk certain distances, and difficulties in daily activities. The total score ranges from 0 to 24, with higher scores indicating more severe symptoms and greater impact on mobility and quality of life.
Time frame: Baseline, Week 4, Week 8, and Week 12
Using the Visual Analogue Scale (VAS) to measure knee pain. Patients rate their pain on a straight line, where 0 means no pain and 10 means the worst pain imaginable. The patient marks a point on the line that represents their pain level, and the score is measured in centimeters or millimeters.
Time frame: Baseline, Week 4, Week 8, and Week 12
The SF-36 questionnaire is widely used to measure perceived health-related quality of life (HRQOL) and daily functioning. It consists of 36 items, which are summarized into two main domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Time frame: Baseline and Week 12
The Kellgren-Lawrence (KL) grading system is a widely used method for classifying the severity of osteoarthritis (OA) based on radiographic findings. It consists of five grades, ranging from 0 to 4 (Normal, Doubtful, Mild, Moderate, Severe)
Time frame: Baseline and Week 12
Joint range of motion (ROM) assessment evaluates the movement capacity of a joint, focusing on its flexibility and mobility. For the extensor and flexor muscle groups, the assessment measures the degree of joint extension (straightening) and flexion (bending).
Time frame: Baseline and Week 12
The time taken to rise from a chair, walk 3 meters, turn, return, and sit down will be recorded. Unit of Measure: Seconds (s)
Time frame: Baseline and Week 12
Participants will be asked to ascend and descend a standardized flight of stairs, and the time required will be recorded. Unit of Measure: Seconds (s)
Time frame: Baseline and Week 12
Aerobic capacity will be assessed using 6-minute walk test to evaluate endurance. Unit of Measure: Meters (m)
Time frame: Baseline and Week 12
Using the ELISA method, measure the serum levels of inflammatory markers, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), prostaglandin E2 (PGE2), tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), interleukin-10 (IL-10), matrix metalloproteinase-3 (MMP-3), and matrix metalloproteinase-13 (MMP-13).
Time frame: Baseline and Week 12
Wrap a flexible measuring tape around the thickest part of the thigh, typically mid-way between the hip and knee. Record the measurement in centimeters or inches.
Chung Shan Medical University
Other
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