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

Korea Health Industry Development Institute0 sites166 target enrollmentApril 2012

ConditionsOsteoporosis

InterventionsExperimental

DrugsExperimental

Overview

Phase: Phase 2
Intervention: Experimental
Conditions: Osteoporosis
Sponsor: Korea Health Industry Development Institute
Enrollment: 166
Primary Endpoint: The change of T-score of bone mineral density(QCT)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

November 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Korea Health Industry Development Institute

Responsible Party

Principal Investigator

Hyun Lee

Professor

Korea Health Industry Development Institute

Eligibility Criteria

Inclusion Criteria

•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)

Arms & Interventions

Experimental

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

Intervention: Experimental

Placebo comparator

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

Intervention: Experimental

Outcomes

Primary Outcomes

The change of T-score of bone mineral density(QCT)

Time Frame: baseline, After 24 weeks(± 3 days) from the baseline of the trial

Secondary Outcomes

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)