The Effect of Bunsimgieum on the Chest Discomfort of Hwa-byung's Major Symptom

Study Overview
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Brief Summary
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The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort of Hwa-byung's major symptom and develope and establish pattern identification system in Hwa-byung.

Official Title
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The Effect of Bunsimgi-eum(Fenxinqiyin) on the Chest Discomfort of Hwa-byung's Major Symptom : Randomized, Double-blinded, Placebo-control Trial

Conditions
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Hwa-byung (Disorder)

Intervention / Treatment
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* Drug: mild-ex-gwarip
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female aged 20-65 subjects who meet structured interview criteria for Hwa-Byung Diagnosis Exclusion Criteria: duration of illness less than 6 months 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bunsimgieum extract<br>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. | Drug: mild-ex-gwarip<br>* three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.<br>* Other names: standard code for item: 200005689;|
| Placebo Comparator: Placebo; corn flour,<br>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. | Other: Placebo<br>* three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hwa-byung, Bunsimgi-eum(Fenxinqiyin)