Healthy adult
Conditions
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Males and females from 40 to 74 years of age (2)Subjects who have knee joint pain (3)Subjects who can understand the purpose and content of this study and agree in writing to participate in this study
Exclusion criteria
Exclusion criteria: (1)Subjects who are classified into II, III or IV grade on the basis of the KL classification (2)Subjects which knee join pain is weaker than pain in other joints (3)Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability (4)Subjects who are suspected gout attack with hyperuricemia (5)Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain (6)Subjects who have performed arthroplasty or need it (7)Subjects who regularly take health food containing bone, cartilage, joint from three month before the screening test to the end of the study and regular users (8)Subjects who regularly use the involved ingredients at least 3 times a week. (9)Subjects who regularly take medicine (10)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test (11)Subjects who get an intense exercise to make excessive load on the joints (12)Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test (13)Subjects who regularly use a stick or supporter (14)Subjects who periodically conduct actions that may affect on the efficacy evaluation (15)Subjects who get a diagnosis of malignancy, are under treatment for cranial nerve disease, cardiac disease, renal disease, diabetes and thyroid dysfunction, and have a history of serious disorder such as hepatic disease (16)Subjects who drink alcohol in large quantities (17)Subjects who have at risk of developing allergies related to the test food (18)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (19)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period (20)Subjects who intend to become pregnant or lactating (21)Subjects who are judged as unsuitable for this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JKOM at before, 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| JKOOS, JOA, knee range of motion, VAS (knee pain at rest, walking, climbing stairs), at before, 6 and 12 weeks and JLEQ, high-sensitivity CRP, MMP-1, MMP-3, MMP-13, IL-1beta, TNF-alpha, IL-6, PGE2, and HO-1 at before and 12 weeks | — |
Countries
Japan
Contacts
Public ContactTakashi Nakagawa
EP Mediate Co., Ltd. Foods Department, Clinical Research Planning Department
Outcome results
None listed