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Completed

NCT Number: NCT02592161

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 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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Experimental

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 hydrate, Corn starch, Caramel pigment)

Three times a day, oral administration for 24weeks

Other names: Chung A Won

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Korea Health Industry Development Institute

Other Gov

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2015
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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