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| Name | Class |
|---|---|
| BLOOMAGE BIOTECHNOLOGY CORPORATION LIMITED | UNKNOWN |
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This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.
In this study, the investigators will evaluate the knee condition before and after the intervention. The groups to be compared are two different doses of UltraHA® and a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid 150 mg | Active Comparator | Take 150 mg/day of hyaluronic acid. |
|
| Hyaluronic Acid 80 mg | Active Comparator | Take 80 mg/day of hyaluronic acid. |
|
| Placebo | Placebo Comparator | Take 0 mg/day of hyaluronic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UltraHA® 75 mg/capsule | Dietary Supplement | Take 2 capsules per day at any time. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at Week 12 | The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of responses is evaluated as the WOMAC scores. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Each WOMAC subscale score at Week 12 | The WOMAC contains 24 questions, including pain for 5 questions, stiffness for 2 questions, and physical function for 17 questions, answered on a range of 0 (mildest) to 4 (most severe). The sum of each subscale response is evaluated as the WOMAC subscale score. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsuyoshi Takara, MD | Medical Corporation Seishinkai, Takara Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nerima Medical Association Minami-machi Clinic | Nerima-ku | Tokyo | 176-0002 | Japan | ||
| Medical Corporation Seishinkai, Takara Clinic |
Data sharing will be discussed among the research affiliates after the study is completed.
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| UltraHA® 40 mg/capsule |
| Dietary Supplement |
Take 2 capsules per day at any time. |
|
| Placebo | Dietary Supplement | Take 2 capsules per day at any time. |
|
| Subjective symptoms at Week 12 |
Assess knee pain, stiffness, discomfort, and health using visual analogue scale. There is a 100 mm straight line with the best and worst degree of sensation indicated at both ends, and the current degree of sensation is marked on the line with the best imaginable state being 0 and the worst state being 100. |
| Week 12 |
| Shinagawa-Ku |
| Tokyo |
| 141-0022 |
| Japan |