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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 and Welfare

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

ClinicalTrials.gov processed this record on November 20, 2014