ArthritisNCT06658821
The Effect of LDL557 on Improving Degenerative Arthritis in the Elderly
A study testing LDL557-HK capsule in people with Arthritis and Joint Pain, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Arthritis, Joint Pain
- What is being tested?
- LDL557-HK capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Feb 2025to 30 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Rheumatoid arthritis.
- Those who have had joint injections within 6 months.
- Those with cardiovascular and cerebrovascular, rheumatoid or mental diseases.
- Patients undergoing cancer treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Arthritis, Joint Pain
- Being tested
- LDL557-HK capsule, Placebo Capsule
- Medical subject headings
- Arthritis, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDL557-HK capsuleDietary 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.
Placebo CapsuleDietary supplement
Subjects will take once a day during the experimental period. one placebo capsule within 30 minutes before lunch.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: LDL557-HK capsule |
| Placebo capsule | Placebo comparator | Subjects will take one placebo capsule within 30 minutes before lunch during the experimental period. Receives: Dietary Supplement: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (11)
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.
Measured: Baseline, Week 4, Week 8, and Week 12
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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Baseline and Week 12
Aerobic Capacity
Aerobic capacity will be assessed using 6-minute walk test to evaluate endurance. Unit of Measure: Meters (m)
Measured: 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).
Measured: 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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start27 Feb 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- SYNBIO TECH INC. Kaohsiung Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658821
- Sponsor's protocol ID
- CS2-24147
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No