Arthritis, Joint Pain
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLDL557-HK capsule
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.
DIETARY_SUPPLEMENTPlacebo Capsule
Subjects will take once a day during the experimental period. one placebo capsule within 30 minutes before lunch.
Sponsors
Chung Shan Medical University
SYNBIO TECH INC. Kaohsiung Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* BMI 18-40 kg/m2; * Those with early stage degenerative arthritis symptoms judged by X-ray to be Kellgren-Lawrence Grading Scale level 1 or 2, and the physician determines that long-term treatment is not needed or WOMAC score\>2.0 or WOMAC total scale score\>12 or VAS score ≦6.
Exclusion criteria
* Smoking * alcoholism * diabetes * breastfeeding women and pregnant women. * Those consuming dietary supplements were excluded. * Those who use non-steroidal anti-inflammatory analgesics and those who have had joint surgery. * Rheumatoid arthritis. * Those who have had joint injections within 6 months. * Those with cardiovascular and cerebrovascular, rheumatoid or mental diseases. * Patients undergoing cancer treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS | 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. |
| Lequesne's index | 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. |
| VAS | 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. |
| Quality of life (QOL) SF-36 | 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). |
| Kellgren-Lawrence Grade | 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) |
| Joint range of motion assessment | 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). |
| Timed Up and Go Test | 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) |
| Stair Climb Test | 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) |
| Aerobic Capacity | Baseline and Week 12 | Aerobic capacity will be assessed using 6-minute walk test to evaluate endurance. Unit of Measure: Meters (m) |
| Inflammation assessment | 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). |
| Thigh circumference | 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. |
Countries
Taiwan
Outcome results
None listed