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

K

Korea Health Industry Development Institute

Status and phase

Completed
Phase 2

Conditions

Osteoporosis

Treatments

Drug: Experimental

Study type

Interventional

Funder types

Other

Identifiers

NCT02592161
B110051

Details and patient eligibility

About

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.

Enrollment

166 patients

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1)Female more than 50 years old in osteoporosis

Exclusion criteria

  • Wash out peroid: using agents more than 3 months against osteoporosis
  • Subject who takes drugs that may affect the clinical trials (Corticosteroids, anticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic)
  • Subject who has a chronic liver disease, thyroid disease and chronic renal disease
  • Subject who is chronic alcoholics and undernourished
  • Other conditions were not suitable in study : Severe physical defects mental defects
  • 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

166 participants in 2 patient groups, including a placebo group

Experimental
Experimental group
Description:
Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks
Treatment:
Drug: Experimental
Placebo comparator
Placebo Comparator group
Description:
Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks
Treatment:
Drug: Experimental

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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