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| Name | Class |
|---|---|
| SYNBIO TECH INC. Kaohsiung Taiwan | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDL557-HK capsule | Experimental | Subjects will take one capsule of the experimental group(LDL557-HK capsule) within 30 minutes before lunch during the experimental period. |
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| Placebo capsule | Placebo Comparator | Subjects will take one placebo capsule within 30 minutes before lunch during the experimental period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDL557-HK capsule | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC | 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). | Baseline, Week 4, Week 8, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS | 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. | Baseline, Week 4, Week 8, and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| Placebo Capsule | Dietary Supplement | Subjects will take once a day during the experimental period. one placebo capsule within 30 minutes before lunch. |
|
| Lequesne's index | 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. | Baseline, Week 4, Week 8, and Week 12 |
| VAS | 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. | Baseline, Week 4, Week 8, and Week 12 |
| Quality of life (QOL) SF-36 | 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). | Baseline, Week 4, Week 8, and Week 12 |
| Kellgren-Lawrence Grade | 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) | Baseline and Week 12 |
| Joint range of motion assessment | 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). | Baseline and Week 12 |
| Timed Up and Go Test | The time taken to rise from a chair, walk 3 meters, turn, return, and sit down will be recorded. Unit of Measure: Seconds (s) | Baseline and Week 12 |
| Stair Climb Test | 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) | Baseline and Week 12 |
| Aerobic Capacity | Aerobic capacity will be assessed using 6-minute walk test to evaluate endurance. Unit of Measure: Meters (m) | Baseline and Week 12 |
| Inflammation assessment | 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). | Baseline and Week 12 |
| Thigh circumference | 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. | Baseline and Week 12 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |