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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyun Lee, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier:
NCT02592161
First received: October 29, 2015
Last updated: NA
Last verified: October 2015
History: No changes posted
  Purpose
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.

Condition Intervention Phase
Osteoporosis
Drug: Experimental
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Korea Health Industry Development Institute:

Primary Outcome Measures:
  • The change of T-score of bone mineral density(QCT) [ Time Frame: baseline, After 24 weeks(± 3 days) from the baseline of the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of T-score [ Time Frame: baseline, After 4 weeks, 12 weeks from the baseline of the trial ] [ Designated as safety issue: No ]
  • The change of osteoporosis-related indicators of blood tests [ Time Frame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial ] [ Designated as safety issue: No ]
  • The change of ODI(Oswestry Disability Index) [ Time Frame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial ] [ Designated as safety issue: No ]
  • The change of QVAS(Quardruple Visual Analog Scale) [ Time Frame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial ] [ Designated as safety issue: No ]
  • The change of kupperman index [ Time Frame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial ] [ Designated as safety issue: No ]
  • The change of shin-huh symptoms [ Time Frame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial ] [ Designated as safety issue: No ]
  • The change of quality of life using SF-36 [ Time Frame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: April 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks
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

Other Name: Chung A Won
Placebo Comparator: Placebo comparator
Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks
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

Other Name: Chung A Won

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Hyun Lee, Professor, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier: NCT02592161     History of Changes
Obsolete Identifiers: NCT01771510
Other Study ID Numbers: B110051 
Study First Received: October 29, 2015
Last Updated: October 29, 2015
Health Authority: Korea: Ministry for Health and Welfare

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 26, 2016