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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270048
First Posted: January 5, 2011
Last Update Posted: January 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Korea Health Industry Development Institute
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sun-Tae. Kim, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier: NCT01270048     History of Changes
Other Study ID Numbers: B070057
First Submitted: January 4, 2011
First Posted: January 5, 2011
Last Update Posted: January 5, 2011
Last Verified: September 2009

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