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

Korea Health Industry Development Institute

Status and phase: Completed; Phase 3

Conditions: Hwa-byung (Disorder)

Treatments: Other: Placebo; Drug: mild-ex-gwarip

Study type: Interventional

Funder types: Other

Identifiers

NCT01270048

B070057

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups, including a placebo group

Bunsimgieum extract

Experimental group

Description:

* 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.

Treatment:

Drug: mild-ex-gwarip

Placebo; corn flour,

Placebo Comparator group

Description:

* 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.

Treatment:

Other: Placebo