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

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

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.

Study Overview

• Status: Completed
• Conditions: Hwa-byung (Disorder)
• Intervention / Treatment: Drug: mild-ex-gwarip; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Choong-Chung-Do
    • Daejon, Choong-Chung-Do, Korea, Republic of
      • Oriental Hospital of Daejon University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: mild-ex-gwarip; three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.; Other Names: standard code for item: 200005689
Placebo Comparator: 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.	Other: Placebo; three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.

Collaborators and Investigators

• Sponsor: Korea Health Industry Development Institute
• Investigators: Principal Investigator: In-Chul Jung, Ph.D, Oriental Hospital of Daejon University

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2011
• Last Update Submitted That Met QC Criteria: January 4, 2011
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Hwa-byung, Bunsimgi-eum(Fenxinqiyin)
• Other Study ID Numbers: B070057