We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
January 4, 2011
January 5, 2011
January 5, 2011
May 2008
March 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Hwa-byung (Disorder)
  • 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
  • Other: Placebo
    three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
  • 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.
    Intervention: Drug: mild-ex-gwarip
  • 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.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
August 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01270048
B070057
Yes
Not Provided
Not Provided
Sun-Tae. Kim, Korea Health Industry Development Institute
Korea Health Industry Development Institute
Not Provided
Principal Investigator: In-Chul Jung, Ph.D Oriental Hospital of Daejon University
Korea Health Industry Development Institute
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
To Top