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

Phase 2

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Experimental

• Registration Number: NCT02592161
• Lead Sponsor: Korea Health Industry Development Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-10
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Last Update Submitted: 2015-10-29
• Study First Posted: 2015-10-30
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Experimental	Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks
Placebo comparator	Experimental	Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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