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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02592161

Enrollment

166

Registered

2015-10-30

Start date

2012-04-30

Completion date

2013-11-30

Last updated

2015-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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.

Interventions

DRUGExperimental

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

50 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Measure	Time frame
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 quality of life using SF-36	baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
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 shin-huh symptoms	baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026