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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sihogayonggolmoryeo-tang extract | Experimental |
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| Placebo; corn flour, | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIHOGAYONGGOLMORYU TANG EXTRACT GRAN | Drug | three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BOK NAM SEO | Contact | florence73@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| In-Chul Jung, Ph.D | Oriental Hospital of Daejon University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oriental Hospital of Daejon University | Recruiting | Daejeon | Choong-Chung-Do | South Korea |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Placebo | Other | three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks. |
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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 |