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

Phase 3

Completed

• Conditions: Hwa-byung (Disorder)
• Interventions: Drug: mild-ex-gwarip; Other: Placebo

• Registration Number: NCT01270048
• Lead Sponsor: Korea Health Industry Development Institute

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-03
• Study Completion: 2009-08
• Status Verified: 2009-09
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Last Update Submitted: 2011-01-04
• Study First Posted: 2011-01-05
• Last Update Posted: 2011-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bunsimgieum extract	mild-ex-gwarip	* 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.
Placebo; corn flour,	Placebo	* 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.

Trial Locations

Locations (1)

Oriental Hospital of Daejon University; 🇰🇷 Daejon, Choong-Chung-Do, Korea, Republic of