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

NCT01270048 | Completed Phase 3 DMC

• 1 other identifier: B070057
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hwa-byung (Disorder)

Keywords

Hwa-byung, Bunsimgi-eum(Fenxinqiyin)

Study Arms (2)

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.

Drug: mild-ex-gwarip

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.

Other: Placebo

Interventions

mild-ex-gwarip DRUG

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

Also known as: standard code for item: 200005689

Bunsimgieum extract

Placebo OTHER

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

Placebo; corn flour,

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female aged 20-65
• subjects who meet structured interview criteria for Hwa-Byung Diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Health Industry Development Institute: lead

Study Sites (1)

Oriental Hospital of Daejon University

Daejeon, Choong-Chung-Do, South Korea

Location

Study Officials

• In-Chul Jung, Ph.D

  Oriental Hospital of Daejon University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 5, 2011

Record last verified: 2009-09

Locations

KR (1)