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

NCT02592161 | Completed Phase 2

• 1 other identifier: B110051
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• The change of T-score of bone mineral density(QCT)

  baseline, After 24 weeks(± 3 days) from the baseline of the trial

Secondary Outcomes (7)

• The change of T-score

  baseline, After 4 weeks, 12 weeks from the baseline of the trial

• The change of osteoporosis-related indicators of blood tests

  baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial

• The change of ODI(Oswestry Disability Index)

  baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial

• The change of QVAS(Quardruple Visual Analog Scale)

  baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial

• The change of kupperman index

  baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial

Study Arms (2)

Experimental

EXPERIMENTAL

Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks

Drug: Experimental

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

Interventions

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

Also known as: Chung A Won

Experimental; Placebo comparator

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )Female more than 50 years old in osteoporosis

You may not qualify if:

• 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)

Sponsors & Collaborators

• Korea Health Industry Development Institute: lead

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: October 30, 2015
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 30, 2015

Record last verified: 2015-10