Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Single Center, Double Blind, Parallel, Placebo-controlled Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Experimental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1)Female more than 50 years old in osteoporosis Exclusion Criteria: Wash out peroid: using agents more than 3 months against osteoporosis Subject who takes drugs that may affect the clinical trials (Corticosteroids, anticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic) Subject who has a chronic liver disease, thyroid disease and chronic renal disease Subject who is chronic alcoholics and undernourished Other conditions were not suitable in study : Severe physical defects mental defects Pregnant woman Subject who is not calibrated hypercalcemia/hypocalcemia Secondary osteoporosis : Subject who takes drugs(Glucocorticoid, Diabetes Medications) Subject who has 60% more fracture risk in FRAX(WHO fracture risk assessment tool)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks | Drug: Experimental<br>* 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<br>* Other names: Chung A Won;|
| Placebo Comparator: Placebo comparator<br>Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks | Drug: Experimental<br>* 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<br>* Other names: Chung A Won;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |