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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01771510
• Other study ID #: B110051
• Status: Recruiting
• Phase: Phase 2
• First received: December 13, 2012
• Last updated: January 16, 2013
• Start date: April 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2013
• Source: Ministry of Health & Welfare, Korea
• Contact: hyun Lee
• Phone: 82-41-521-7578
• Email: lh2000[@]dju.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Female more than 50 years old

• Clnical diagnosis of osteoporosis

Exclusion Criteria:

• Wash out peroid

• Subject who takes drugs that may affect the clinical trials (Corticosteroids, a nticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic)

• Subject who has a chronic liver disease, thyroid disease and chronic renal disease

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diseases of the Musculo-skeletal System and Connective Tissue
• Osteoporosis

Intervention

Drug:
• Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger)
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

Locations

Country	Name	City	State
Korea, Republic of	Cheonan Oriental Hospital of Daejeon University	Cheonan	Chungcheongnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in T-score of bone mineral density(QCT) at 24 weeks		baseline, After 24 weeks(± 3 days) from the baseline of the trial	Yes
Secondary	Change from baseline in T-score of bone mineral density(QCT)		baseline, After 4 weeks, 12 weeks from the baseline of the trial	Yes
Secondary	The change of osteoporosis-related indicators of blood tests		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	Yes
Secondary	The change of ODI(Oswestry Disability Index)		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	Yes
Secondary	The change of QVAS(Quardruple Visual Analog Scale)		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	Yes
Secondary	The change of kupperman index		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	Yes
Secondary	The change of shin-huh symptoms		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	Yes
Secondary	The change of quality of life using SF-36		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	Yes