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A 12-week, randomized, double blind, placebo-controlled Clinical Trial for the evaluate the efficacy and safety of LB-P12 on joint and cartilage health

A 12-week, randomized, double blind, placebo-controlled Clinical Trial for the evaluate the efficacy and safety of LB-P12 on joint and cartilage health

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010221
Enrollment
100
Registered
2025-02-21
Start date
2023-12-12
Completion date
Unknown
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Treatment group - Study drug : LB-P12 350mg(LB-P12 233mg/day), etc. - Once a day, once a capsule, take it with water after dinner, 12 weeks Placebo group - placebo : 350mg of Myc

Sponsors

LISCure Biosciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults under the age of 40 to 75 regardless of gender 2. Visual Analysis Scale (VAS) 3/10 or higher 3. A person whose Kellgren & Lawrence grading scale falls under grade 1 or 2 due to "Both Knee Joint AP" 4. A person who has consented to the test consent written by the applicant as a subject of this test because normal physical activity is possible

Exclusion criteria

Exclusion criteria: 1. Those who have a history of bone fractures within the past year 2. Those who have a torn meniscus 3. Those who have periarticular bone spurs, irregular joint surfaces, and subchondral cysts, and assessed to have moderate osteoarthritis 4. Those who have used COX-2 inhibitors, NSAIDs, or joint-impacting supplements (e.g., glucosamine, green-lipped mussel oil complex, Boswellia extract, chondroitin, MSM, vitamin D, collagen, turmeric extract, or Taibo extract) within 4 weeks before screening, or plan to take them during the study 5. Those who have taken probiotics or lactic acid bacteria within 2 weeks before screening 6. Those who currently undergoing treatment for thyroid disorders 7. Those with kidney disease or a serum creatinine level of 1.4 mg/dL or higher 8. Those who have proteinuria of 2+ or higher 9. Those with liver disease or AST/ALT levels of 100 IU/L or higher 10. Those with uncontrolled hypertension or cardiovascular conditions, such as angina or myocardial infarction 11. Those taking medication for psychiatric disorders (intermittent sleep medication is excluded) 12. Those who have taken herbal or traditional medicine within the past 2 months 13. Those who have taken any investigational drugs within the last 4 weeks 14. Those requiring ongoing medications that could potentially impact the study results 15. Those with a history of gastrointestinal surgery (except appendectomy) 16. Pregnant or breastfeeding individuals 17. Those with alcohol dependency or those who consume alcohol four or more times per week 18. Those with known allergies to the test product or its components 19. Those deemed uncooperative or otherwise unsuitable for study participation, as assessed by the researcher 20. Those whom the principal investigator determines to have arthritis caused by factors other than degenerative conditions

Design outcomes

Primary

MeasureTime frame
WOMAC(Western Ontario and McMaster Universities) questionnaire total score/pain/joint stiffness/physical function score variation

Secondary

MeasureTime frame
VAS(Visual Analogue Scale);Anti-inflammatory indicators (CRP concentration, ESR);inflammatory indicator(IL-1ß, IL-6, TNF-a) ;serum COMP concentration;Joint space width;Quality of Life Survey (EQ-5D-5L)

Countries

Korea, Republic of

Contacts

Public ContactHan seong ho

Dong-A University

handsomdr@hanmail.net+82-51-240-2591

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026