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: Completed

Administrative data

• NCT number: NCT02592161
• Other study ID #: B110051
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2015
• Last updated: October 29, 2015
• Start date: April 2012
• Est. completion date: November 2013

Study information

• Verified date: October 2015
• Source: Korea Health Industry Development Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• 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: Completed
• Enrollment: 166
• 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:

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

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea Health Industry Development Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of T-score of bone mineral density(QCT)		baseline, After 24 weeks(± 3 days) from the baseline of the trial	No
Secondary	The change of T-score		baseline, After 4 weeks, 12 weeks from the baseline of the trial	No
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	No
Secondary	The change of ODI(Oswestry Disability Index)		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	No
Secondary	The change of QVAS(Quardruple Visual Analog Scale)		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	No
Secondary	The change of kupperman index		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	No
Secondary	The change of shin-huh symptoms		baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial	No
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	No