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A randomized, single center, double blind, parallel, placebo-controlled, clinical study of efficacy and safety of Chung A Won and placebo for 24 weeks three times a day on the improvement of osteoporosis and symptoms in Women's older than 50 patients with osteoporosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks |
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| Placebo comparator | Placebo Comparator | Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Drug | Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of T-score of bone mineral density(QCT) | baseline, After 24 weeks(± 3 days) from the baseline of the trial |
| Measure | Description | Time Frame |
|---|---|---|
| The change of T-score | baseline, After 4 weeks, 12 weeks from the baseline of the trial | |
| The change of osteoporosis-related indicators of blood tests | baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial |
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Inclusion Criteria:
1)Female more than 50 years old in osteoporosis
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| The change of ODI(Oswestry Disability Index) | baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial |
| The change of QVAS(Quardruple Visual Analog Scale) | baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial |
| The change of kupperman index | baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial |
| The change of shin-huh symptoms | baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial |
| The change of quality of life using SF-36 | baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial |
| D009750 |
| Nutritional and Metabolic Diseases |