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

Sponsor

Korea Health Industry Development Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02592161

Collaborator

(none)

166

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Experimental	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Experimental

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

Drug: Experimental

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

Other Names:

Chung A Won

Placebo Comparator: Placebo comparator

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

Drug: Experimental

Other Names:

Chung A Won

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Korea Health Industry Development Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyun Lee, Professor, Korea Health Industry Development Institute

ClinicalTrials.gov Identifier:

NCT02592161

Other Study ID Numbers:

B110051
NCT01771510

First Posted:

Oct 30, 2015

Last Update Posted:

Oct 30, 2015

Last Verified:

Oct 1, 2015

Additional relevant MeSH terms:

Osteoporosis

Study Results

No Results Posted as of Oct 30, 2015