Healthy volunteer
Conditions
Interventions
Proteoglycan capsules are ingested for 12 consecutive weeks at 10mg.
Sponsors
TTC Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females at the ages of 40 to 85 2) Subjects who are classified into 0-III grade on the basis of the Kellgren-Lawrence classification. (Mainly grade 0 to II)
Exclusion criteria
Exclusion criteria: 1) Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability 2) Subjects who are suspected gouty attack with hyperuricemia 3) Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain 4) Subjects who have performed arthroplasty or need it 5) Subjects who regularly take health food containing proteoglycan or related to bone and joint wellness from two week before the screening test to the end of the study 6) Subjects who regularly take medicine, except in the case of permission to take anti-pain and anti-inflammatory drug by physician 7) Subjects who is taking medicine that affects cartilage or bone metabolism marker such as bisphosphonate, hormone therapy 8) Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within two week before the screening test 9) Subjects who regularly take medicine 10) Subjects who get an intense exercise to make excessive load on the joints 11) Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within three month before the screening test 12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 13) Subjects who are judged unsuitable from clinical examination before ingestion 14) Subjects who need to take warfarin during the study 15) Subjects who have possibility of allergy symptoms onset by the raw material in test diet 16) Subjects who intend to become pregnant or lactating 17) Subjects who intend to participate in study period 18) Subjects who are judged as unsuitable for this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Japanese Knee Osteoarthritis Measure (JKOM), Japanese Orthopaedic Association score (JOA score) | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale(VAS), C2C, CPII, HA, CTX-II, NTx Hematologic test, Biochemistry test, Urinalysis | — |
Countries
Japan
Contacts
Public ContactTakashi Nakagawa
TTC Co., Ltd Clinical Research Planning Department
Outcome results
None listed