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

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ClinicalTrials.gov Identifier: NCT02592161
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Hyun Lee, Korea Health Industry Development Institute

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Experimental Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2012
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The change of T-score of bone mineral density(QCT) [ Time Frame: baseline, After 24 weeks(± 3 days) from the baseline of the trial ]

Secondary Outcome Measures :
  1. The change of T-score [ Time Frame: baseline, After 4 weeks, 12 weeks from the baseline of the trial ]
  2. 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 ]
  3. The change of ODI(Oswestry Disability Index) [ Time Frame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial ]
  4. 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 ]
  5. The change of kupperman index [ Time Frame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial ]
  6. The change of shin-huh symptoms [ Time Frame: baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial ]
  7. 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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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)

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
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015

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