The Effect of Bunsimgieum on the Chest Discomfort of Hwa-byung's Major Symptom
NCT ID: NCT01270048
Last Updated: 2011-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
144 participants
INTERVENTIONAL
2008-05-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bunsimgieum extract
* name of product: 'mild-x-gwarip'
* standard code for item: 200005689
* shape, type: extract(brown)
* usage, content: adults;three times a day, each taken before or between meals
* dose, standard: 2.5g for each sack, capsulated
* storage : airtight container, stored in room temperature
* expiration date : 36months after manufacture
* macufacturing company: KyungBangnShinYak inc.
mild-ex-gwarip
three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
Placebo; corn flour,
* raw material: total contents(500㎎); cornstarch 50.0%(250.0㎎), 당수화물 49.45%(247.25㎎), caramel pigment 0.5%(2.5㎎), SsangHwa fragrance 0.05%(0.25㎎)
* shape, type: extract(brown)
* usage, dose: adults: three times a day, 1 sack before or between meals
* dose, standard: 2.5g for each sack, capsulated
* storage : airtight container, stored in room temperature
* expiration date : 36 months after manufacture
* manufacturing company: KyungBangnShinYak inc.
Placebo
three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
Interventions
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mild-ex-gwarip
three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
Placebo
three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* subjects who meet structured interview criteria for Hwa-Byung Diagnosis
Exclusion Criteria
* current or past history of delusions, hallucination
* past history of at least one manic episode, hypomanic episode, or mixed episode
* current or past history of alcohol abuse or alcohol dependence history
* taking substances(e.g. steroids) which might affect symptoms
* medical conditions(e.g. hyperthyroidism, hypothyroidism, heart disease) that might affect symptoms
* current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure
* pregnancy, lactation, women not using medically accepted means of birth control
* considered not apt to carry out clinical trial
20 Years
65 Years
ALL
No
Sponsors
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Korea Health Industry Development Institute
OTHER_GOV
Responsible Party
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Korea Health Industry Development Institute
Principal Investigators
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In-Chul Jung, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Oriental Hospital of Daejon University
Locations
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Oriental Hospital of Daejon University
Daejeon, Choong-Chung-Do, South Korea
Countries
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Other Identifiers
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B070057
Identifier Type: -
Identifier Source: org_study_id
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