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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Subjects are given EuBone® capsules, 4 capsules ×500mg/capsule per day for 360 days.
Subjects are given placebo capsules, 4 capsules ×500mg/capsule per day for 360 days.
Shandong Provincial Qianfoshan Hospital
Ji'nan, Shandong, China
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
Time frame: on day 360 after administration
The change of lumbar vertebra bone density
To evaluate the change of lumbar vertebra bone density from baseline
Time frame: on day 360 after administration
The incidence rate of adverse events
To evaluate the incidence rate of adverse events
Time frame: Through study completion, an average of 360 days
The response rate of quality of life score
To evaluate the improvement rate of quality of life score from baseline
Time frame: 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
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
Time frame: 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
Time frame: 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
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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
Time frame: 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
Time frame: at 30, 90, 180 and 360 days after administration