Enrolling by invitation NCT06658821
The Effect of LDL557 on Improving Degenerative Arthritis in the Elderly
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LDL557-HK capsule, Placebo Capsule.
- Who it may be relevant to
- Registry conditions: Arthritis, Joint Pain. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement LDL557-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 supplement Placebo Capsule
Subjects will take once a day during the experimental period. one placebo capsule within 30 minutes before lunch.
Primary outcome measures
- WOMAC [Time frame: Baseline, Week 4, Week 8, and Week 12]
Secondary outcome measures (11)
- KOOS [Time frame: Baseline, Week 4, Week 8, and Week 12]
- Lequesne's index [Time frame: Baseline, Week 4, Week 8, and Week 12]
- VAS [Time frame: Baseline, Week 4, Week 8, and Week 12]
- Quality of life (QOL) SF-36 [Time frame: Baseline, Week 4, Week 8, and Week 12]
- Kellgren-Lawrence Grade [Time frame: Baseline and Week 12]
- Joint range of motion assessment [Time frame: Baseline and Week 12]
- Timed Up and Go Test [Time frame: Baseline and Week 12]
- Stair Climb Test [Time frame: Baseline and Week 12]
- Aerobic Capacity [Time frame: Baseline and Week 12]
- Inflammation assessment [Time frame: Baseline and Week 12]
- Thigh circumference [Time frame: Baseline and Week 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Taiwan · 1 center
- Chung Shan Medical University — Taichung
Identifiers
NCT: NCT06658821 · CS2-24147