Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical trial is to evaluate the efficacy and safety of Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) in subjects with mild osteoarthritis (OA).
This is a 12-week, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) in subjects with mild OA. One hundred subjects with mild OA will be recruited and randomly divided into 2 groups, each group will receive Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) or placebo and will take CE or placebo for 12 weeks. Outcomes will be evaluated by self-administered questionnaires and lab test results. The hypothesis is that Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) which as a dietary supplementation may slow down or reverse OA.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cortex Eucommiae(CE) | Experimental | CE capsule administered orally twice daily for 12 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsule administered orally twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE | Dietary Supplement | 550mg capsule (Eucommia ulmoides Oliver extract) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| VAS (Visual Analogue Scale) | VAS to measure changes in joint pain on 6, 12 weeks after administration in comparison with baseline | Change of the week 6, 12 from baseline |
| K-WOMAC (Korean-Western Ontario and McMaster Universities) | K-WOMAC to measure changes in joint pain and function on 6, 12 weeks after administration in comparison with baseline | Change of the week 6, 12 from baseline |
| KSF-36 (Korean-Short Form Health Survey 36) | KSF-36 to measure changes in physical and mental function on 6, 12 weeks after administration in comparison with baseline | Change of the week 6, 12 from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's global impression of change scale | The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject Level of Quality
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hyeon Yeong Ahn, PhD | Jaseng Medical Foundation | Study Director |
| Jae-Heung Cho, KMD,PhD | Kyung Hee University at Gangdong | Principal Investigator |
| Dongwoo Nam, KMD,PhD | Kyunghee University | Principal Investigator |
| Eun-Jung Kim, KMD,PhD | DongGuk University | Principal Investigator |
| In-Hyuk Ha, KMD,PhD | Jaseng Medical Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Korean Medicine Hospital | Seoul | 02447 | South Korea | |||
| Kyung Hee University Korean Medicine Hospital at Gangdong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31852118 | Derived | Ahn HY, Cho JH, Nam D, Kim EJ, Ha IH. Efficacy and safety of Cortex Eucommiae (Eucommia ulmoides Oliver) extract in subjects with mild osteoarthritis: Study protocol for a 12-week, multicenter, randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2019 Dec;98(50):e18318. doi: 10.1097/MD.0000000000018318. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Dietary Supplement |
550mg capsule (Placebo) |
|
| 6 weeks, 12 weeks |
| Investigator's global impression of change scale | The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator Level of Quality
| 6 weeks, 12 weeks |
| ESR (Erythrocyte sedimentation rate) | ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline | Change of the week 12 from baseline |
| CRP (C-reactive protein) | CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline | Change of the week 12 from baseline |
| Seoul |
| 05278 |
| South Korea |
| Dongguk University Bundang Oriental Hospital | Seoul | 13601 | South Korea |