Human study for improving Joint Health of (NEM?) Randomized, double-blind, control clinical Trials

Not Applicable

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0008241
• Lead Sponsor: ARI BnC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-14
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Adults between the ages of 40 and 75
- Subjects with knee KL (Kellgren-Lawrence) grade ?-?
- 30 ~ 100mm factor when measuring VAS
- Subjects with a BMI (Body Mass Index) of 18.5 kg/m2 or more and less than 30 kg
- Subjects who complained of knee discomfort related to exercise or physical activity at any time during the 2 weeks prior to screening
- Subjects who voluntarily decides to participate after hearing a detailed explanation of this study and fully understands it and agrees in writing to abide by the precautions

Exclusion Criteria

- Subjects diagnosed with inflammatory joint disorder according to the American College of Rheumatology (ACR)
- Subjects with moderate or severe synovitis (Kellgren-Lawrence grade III or higher)
- Subjects with meniscus rupture
- Subjects suffering from diseases of the kidney, liver, respiratory system, gastrointestinal tract, cardiovascular system, endocrine system, or nervous system
- Subjects with a history of knee or hip replacement surgery
- Pregnant women, those preparing for pregnancy / lactating women
- Glucosamine sulfate, chondroitin sulfate, intra-articular hyaluronate or
- Subjects who have a history of using systemic or intra-articular glucocorticoids
- Subjects who has a history of taking anti-inflammatory drugs, boswellia, curcumin, omega-3 fatty acids, or collagen supplements within 30 days or has used them chronically
- alcoholic
- Subjects with hyperuricemia and suspected gout
- Subjects with allergies/side effects to the test substance
- Subjects who have participated in other clinical trials within the last 3 months
- Subjects who took painkillers or cold medicine within 1 week of the visit
- Uncontrolled diabetes (HbA1C >7.0%)
- If you have hip or back pain that interferes with the gait or exercise tests used throughout the study
- Subjects who has a history of clinically significant hypersensitivity reaction or who has experience or possibility of hypersensitivity reaction to raw materials (egg shell, egg) for human application test
- Subjects who are judged unsuitable for participation in human application tests by the test director
- Subjects with mental illness such as identity fever, drug addiction, and those undergoing treatment for depression
- Subjects who have a history of treatment for alcoholism or drug abuse
- Subjects with AST or ALT more than 3 times the upper limit of normal
- Subjects whose serum creatinine is more than twice the upper limit of normal

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(WOMAC: Western Ontario and McMaster Universities Osteoarthritis)

Secondary Outcome Measures

Name	Time	Method
VAS: Visual analogue scale, WHOZOL-BREF, inflammatory markers(hs-CRP, ESR, TNF-a, IL-1ß), cartilage markers(COMP, MMP-2, (u)CTX-?), Change in knee gap ;Clinical pathology test (blood, urine test)