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

NCT ID: NCT01270048

Last Updated: 2011-01-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-08-31

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.

Detailed Description

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Conditions

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Hwa-byung (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Group Type EXPERIMENTAL

mild-ex-gwarip

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Intervention Type DRUG

Placebo

three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.

Intervention Type OTHER

Other Intervention Names

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standard code for item: 200005689

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role lead

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

Site Status

Countries

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South Korea

Other Identifiers

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B070057

Identifier Type: -

Identifier Source: org_study_id

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