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

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000594

Enrollment

106

Registered

2012-11-29

Start date

2012-04-16

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : 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 hyd

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Female more than 50 years old in osteoporosis

Exclusion criteria

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)	—

Secondary

Measure	Time frame
The change of T-score;The change of osteoporosis-related indicators of blood tests;The change of ODI(Oswestry Disability Index) ;The change of QVAS(Quardruple Visual Analog Scale);The change of kupperman index;The change of shin-huh symptoms;The change of quality of life using SF-36	—

Countries

Korea, Republic of

Contacts

Public ContactJae hei kang

Cheonan Korean Medicine Hospital of Daejeon University

Outcome results