The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung
- Conditions
- Hwa-byung
- Interventions
- Drug: SIHOGAYONGGOLMORYU TANG EXTRACT GRANOther: Placebo
- Registration Number
- NCT01362114
- Lead Sponsor
- Korea Health Industry Development Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sihogayonggolmoryeo-tang extract SIHOGAYONGGOLMORYU TANG EXTRACT GRAN * 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. Placebo; corn flour, Placebo * 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.
- Primary Outcome Measures
Name Time Method Hamilton Anxiety Scale(HAM-A) 8 weeks 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.
- Secondary Outcome Measures
Name Time Method State-Trait Anxiety Inventory(STAI) 8 weeks 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.
Beck Depression Inventory(BDI) 8 weeks 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.
WHO Quality of Life Abbreviated(WHOQOL-BREF) 8 weeks Quality of life is used to evaluate the general well-being of individuals and societies.
Heart Rate Variability(HRV) 8 weeks 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.
likert scale 8 weeks This scale is used to evaluate the degree of Hwa-byung's major symptom by 5 point measure. (0,1,2,3,4)
Hwa-byung scale 8 weeks 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).
State-Trait Anger Expression Inventory (STAXI) 8 weeks 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.
Insomnia Severity Index (ISI) 8 weeks 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
Instrument of Oriental Medical Evaluation for Hwa-Byung 8 weeks Instrument of Oriental Medical Evaluation for Hwa-Byung is a standard scale to evaluate for Oriental Medical cure in Hwa-Byung
Trial Locations
- Locations (1)
Oriental Hospital of Daejon University
🇰🇷Daejon, Choong-Chung-Do, Korea, Republic of