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| Name | Class |
|---|---|
| Qianfoshan Hospital | OTHER |
| Chenland Nutritionals lnc. | UNKNOWN |
| Jinan Hetai Pharmaceutical Technology Co., LTD | UNKNOWN |
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EuBone is prepared by mixing eucommia ulmoides extract, fructus ulmoides extract and dodder extract in proportion. The aim of this study is to evaluate the effectiveness and safety of EuBone® capsules in slowing bone loss, preventing bone loss, and improving quality of life compared with placebo in Postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug:EuBone® capsule | Experimental | Subjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days. |
|
| control:placebo | Placebo Comparator | Subjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EuBone ® capsule | Drug | Subjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The response rate of Quality of life score from baseline | To evaluate the improvement rate of the Quality of life score from baseline improvement rate | on day 360 after administration |
| The change of lumbar vertebra bone density | To evaluate the change of lumbar vertebra bone density from baseline | on day 360 after administration |
| The incidence rate of adverse events | To evaluate the incidence rate of adverse events | Through study completion, an average of 360 days |
| Measure | Description | Time Frame |
|---|---|---|
| The response rate of quality of life score | To evaluate the improvement rate of quality of life score from baseline | at 30, 90 and 180 days after administration |
| The change of bone mineral density (BMD) at the total hip joint and femoral neck of the subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhao | Contact | +8653188383308 | zhao4wei2@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Qianfoshan Hospital | Ji'nan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Subjects were randomly assigned to the EuBone® capsule treatment group or placebo control group in a 2:1 ratio.
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| placebo | Drug | Subjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days. |
|
To evaluate the change of bone mineral density (BMD) at the total hip joint and femoral neck of the subject after continuous administration of EuBone® capsule compared from baseline |
| at 180 and 360 days after continuous administration of EuBone® capsule |
| The change of bone mineral density of lumbar vertebra (L1~L4) | To evaluate the change of bone mineral density of lumbar vertebra (L1~L4) after continuous administration of EuBone® capsule | at 180 after continuous administration of EuBone® capsule |
| The change of serum n-terminal propeptide (S-PINP) and carboxy-terminal cross-linked peptide of type I procollagen (S-CTX) from baseline | To evaluate the change of serum n-terminal propeptide (S-PINP) and carboxy-terminal cross-linked peptide of type I procollagen (S-CTX) in EuBone® capsule from baseline | at 30, 90, 180 and 360 days after administration |
| The change of parathyroid hormone (PTH), calcitonin (CT) and estrogen levels | To evaluate the changes of parathyroid hormone (PTH), calcitonin (CT) and estrogen levels after continuous treatment with EuBone® capsule from baseline | at 30, 90, 180 and 360 days after administration |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |