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

Korea Health Industry Development Institute

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT02592161

B110051

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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166 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks

Treatment:

Drug: Experimental

Placebo comparator

Placebo Comparator group

Description:

Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks

Treatment:

Drug: Experimental