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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Experimental

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Korea Health Industry Development Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Estimate): October 30, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: B110051