Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 4, 2011
January 4, 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01270048
B070057
Yes
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