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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Ministry of Health & Welfare, Korea
Sponsor:
Information provided by (Responsible Party):
hyun Lee, Ministry of Health & Welfare, Korea
ClinicalTrials.gov Identifier:
NCT01771510
First received: December 13, 2012
Last updated: January 16, 2013
Last verified: January 2013
  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
Diseases of the Musculo-skeletal System and Connective Tissue
Osteoporosis
Drug: Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger)
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 Ministry of Health & Welfare, Korea:

Primary Outcome Measures:
  • Change from baseline in T-score of bone mineral density(QCT) at 24 weeks [ Time Frame: baseline, After 24 weeks(± 3 days) from the baseline of the trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in T-score of bone mineral density(QCT) [ Time Frame: baseline, After 4 weeks, 12 weeks from the baseline of the trial ] [ Designated as safety issue: Yes ]
  • 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: Yes ]
  • 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: Yes ]
  • 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: Yes ]
  • 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: Yes ]
  • 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: Yes ]
  • 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: Yes ]

Estimated Enrollment: 106
Study Start Date: April 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esperimental
Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks
Drug: Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger)

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

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

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


  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female more than 50 years old
  • Clnical diagnosis of osteoporosis

Exclusion Criteria:

  • Wash out peroid
  • Subject who takes drugs that may affect the clinical trials (Corticosteroids, a nticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic)
  • Subject who has a chronic liver disease, thyroid disease and chronic renal disease
  • 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)
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771510

Contacts
Contact: hyun Lee 82-41-521-7578 lh2000@dju.ac.kr

Locations
Korea, Republic of
Cheonan Oriental Hospital of Daejeon University Recruiting
Cheonan, Chungcheongnam-do, Korea, Republic of, 331-957
Contact: Eun Jo    82-41-521-7031    bluesounds@hanmail.net   
Sponsors and Collaborators
Ministry of Health & Welfare, Korea
  More Information

No publications provided

Responsible Party: hyun Lee, Cheonan Oriental Hospital of Daejeon University, Ministry of Health & Welfare, Korea
ClinicalTrials.gov Identifier: NCT01771510     History of Changes
Other Study ID Numbers: B110051
Study First Received: December 13, 2012
Last Updated: January 16, 2013
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 31, 2014