The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung

Phase 4 Study of The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung : A Randomized, Double Blind, Placebo-control Trial

In this randomized, double blinded, Placebo-control Trial, the investigators planned to give Sihogayonggolmoryeo-tang extract or controlled medication on the Anxiety of Hwa-byung.

Study Overview

• Status: Unknown
• Conditions: Hwa-byung
• Intervention / Treatment: Other: Placebo; Drug: SIHOGAYONGGOLMORYU TANG EXTRACT GRAN

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Choong-Chung-Do
    • Daejon, Choong-Chung-Do, Korea, Republic of
      • Recruiting
      • Oriental Hospital of Daejon University
      • Contact: Dae-Myung Park; Phone Number: 82-42-470-9562; Email: pdm8210@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male or female aged 20-65
• subjects who meet structured interview criteria for Hwa-Byung Diagnosis
• subjects who have axiety (more than 17 score in HAMA)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: Sihogayonggolmoryeo-tang extract; name of product: 'SIHOGAYONGGOLMORYU TANG EXTRACT GRAN'; standard code for item: 200005676; 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: SIHOGAYONGGOLMORYU TANG EXTRACT GRAN; three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks; Other Names: standard code for item: 200005676

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety Scale(HAM-A)	The HAM-A (Hamilton Anxiety Scale) is a widely used interview scale that measures the severity of a patient's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory(STAI)	The State-Trait Anxiety Inventory (STAI) was initially conceptualized as a research instrument for the study of anxiety in adults. It is a self-report assessment device which includes separate measures of state and trait anxiety.	8 weeks
Beck Depression Inventory(BDI)	BDI is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity.	8 weeks
WHO Quality of Life Abbreviated(WHOQOL-BREF)	Quality of life is used to evaluate the general well-being of individuals and societies.	8 weeks
Heart Rate Variability(HRV)	Heart rate variability (HRV) is a physiological phenomenon where the time interval between heart beats varies. It is measured by the variation in the beat-to-beat interval.	8 weeks
likert scale	This scale is used to evaluate the degree of Hwa-byung's major symptom by 5 point measure. (0,1,2,3,4)	8 weeks
Hwa-byung scale	This scale is used for self report to evaluate the Hwa-byung's emotional symptoms, physical symptoms and personality traits by 5 point.(0,1,2,3,4).	8 weeks
State-Trait Anger Expression Inventory (STAXI)	The State-Trait Anger Expression Inventory is a inventory which measures the intensity of anger as an emotional state (State Anger) and the disposition to experience angry feelings as a personality trait (Trait Anger). Items consist of 4-point scales that assess intensity of anger at a particular moment and the frequency of anger experience, expression, and control.	8 weeks
Insomnia Severity Index (ISI)	The Insomnia Severity Index is a series of questions, seven in total, designed by medical professionals to help gauge the seriousness of a person's insomnia. The seven questions have numerical value, and the total is added up at the end of the process to give a total that symbolizes the seriousness of the problem	8 weeks
Instrument of Oriental Medical Evaluation for Hwa-Byung	Instrument of Oriental Medical Evaluation for Hwa-Byung is a standard scale to evaluate for Oriental Medical cure in Hwa-Byung	8 weeks

Collaborators and Investigators

• Sponsor: Korea Health Industry Development Institute
• Investigators: Principal Investigator: In-Chul Jung, Ph.D, Oriental Hospital of Daejon University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): May 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: May 25, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 27, 2011

Study Record Updates

• Last Update Posted (Estimate): April 18, 2012
• Last Update Submitted That Met QC Criteria: April 16, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Anxiety; Hwa-byung; Sihogayonggolmoryeo-tang
• Other Study ID Numbers: B080009