Trial | NCT01270048  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mild-x-gwarip ...

  • Study Participants

    144
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.
Study Started
May 31
2008
Primary Completion
Mar 31
2009
Study Completion
Aug 31
2009
Last Update
Jan 05
2011
Estimate

Drug mild-ex-gwarip

three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.

  • Other names: standard code for item: 200005689

Other Placebo

three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.

Bunsimgieum extract Experimental

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.

Placebo; corn flour, Placebo Comparator

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.

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
No Results Posted