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

This study has been completed.
Sponsor:
Information provided by:
Korea Health Industry Development Institute
ClinicalTrials.gov Identifier:
NCT01270048
First received: January 4, 2011
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hwa-byung (Disorder)
 Drug: mild-ex-gwarip
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Bunsimgi-eum(Fenxinqiyin) on the Chest Discomfort of Hwa-byung's Major Symptom : Randomized, Double-blinded, Placebo-control Trial

Further study details as provided by Korea Health Industry Development Institute:

Enrollment: 144
Study Start Date: May 2008
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270048

Locations
Korea, Republic of
Oriental Hospital of Daejon University
Daejon, Choong-Chung-Do, Korea, Republic of
Sponsors and Collaborators
Korea Health Industry Development Institute
Investigators
Principal Investigator: In-Chul Jung, Ph.D Oriental Hospital of Daejon University
  More Information

No publications provided

Responsible Party: Sun-Tae. Kim, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier: NCT01270048     History of Changes
Other Study ID Numbers: B070057
Study First Received: January 4, 2011
Last Updated: January 4, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Korea Health Industry Development Institute:
Hwa-byung, Bunsimgi-eum(Fenxinqiyin)

ClinicalTrials.gov processed this record on May 21, 2013