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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Hwa-byung

Intervention / Treatment
-----------------
* Drug: SIHOGAYONGGOLMORYU TANG EXTRACT GRAN
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sihogayonggolmoryeo-tang extract<br>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<br>* three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks<br>* Other names: standard code for item: 200005676;|
| Placebo Comparator: Placebo; corn flour,<br>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<br>* three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hwa-byung, Sihogayonggolmoryeo-tang, Anxiety