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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea Health Industry Development Institute

Criteria

Inclusion Criteria:

1)Female more than 50 years old in osteoporosis

Exclusion Criteria:

1. Wash out peroid: using agents more than 3 months against osteoporosis

2. Subject who takes drugs that may affect the clinical trials (Corticosteroids, anticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic)

3. Subject who has a chronic liver disease, thyroid disease and chronic renal disease

4. Subject who is chronic alcoholics and undernourished

5. Other conditions were not suitable in study : Severe physical defects mental defects

6. Pregnant woman

7. Subject who is not calibrated hypercalcemia/hypocalcemia

8. Secondary osteoporosis : Subject who takes drugs(Glucocorticoid, Diabetes Medications)

9. Subject who has 60% more fracture risk in FRAX(WHO fracture risk assessment tool)