Generalized Anxiety DisorderPhase 3NCT01285115
The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form
A Phase 3 study testing KyungBangn-Gamisoyosan-x-gwarip and KyungBangn Gamisoyosan in people with Generalized Anxiety Disorder, run by Korea Health Industry Development Institute at 1 site in South Korea.
Trial summary
In this randomized, double blinded, Parallel-controlled study, the investigators planned to give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of generalized anxiety disorder according to dosage form. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- KyungBangn-Gamisoyosan-x-gwarip and KyungBangn Gamisoyosan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 20-65
- (Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰ) subjects who meet Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰof generalized anxiety disorder
Who cannot join
- Currrent or past history of delusions, halucination
- 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. antianxiety drugs, antidepressant, antipsychotic drug, steroids, female hormonal drug, L-dopa, digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine) which might affect symptoms
- Medical conditions(e.g. myocardial infarction,brain tumor, multiple sclerosis, pancreatic disease, hyperthyroidism, hypothyroidism, Addison disease, Cushing disease, rheumarthritis, cancer, CVA, epilepsy, anemia, pituitarium disease, Vit B12 deficiency disease, PMS) 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Oriental Hospital of Daejon University
Daejeon, Choong-Chung-Do
About this study
Official title: Phase 3 The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form : A Randomized, Double Blind, Parallel-controlled Trial
In this randomized, double blinded, Parallel-controlled study, the investigators planned to give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of generalized anxiety disorder according to dosage form.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Placebo, KyungBangn-Gamisoyosan-x-gwarip, KyungBangn Gamisoyosan
- Keywords
- Generalized anxiety disorder, Jingji-zhengchong, Gamisoyosan, anxiety
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
KyungBangn-Gamisoyosan-x-gwaripDrug
Also called standard code for item : 200005799
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
KyungBangn GamisoyosanDrug
Also called standard code for item: 200005591
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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, content: adults;three times a day each sack taken before or between meals
* dose, standard: for each sack 7.67g
* storage : airtight container, stored in room temperature
* expiration date : after manufacture 36 month
* macufacturing company: KyungBangnShinYak inc. Receives: Drug: Placebo |
| Gamisoyosan extract | Active comparator | * name of product: KyungBangn-Gamisoyosan-x-gwarip
* standard code for item : 200005799
* shape, type: extract(grayish brown)
* usage, content : adults;three times a day , each sack taken before or between meals
* dose, standard: 7.67g for each sack
* storage : airtight container, stored in room temperature expiration date : after manufacture 36 month macufacturing company: KyungBangnShinYak inc. Receives: Drug: KyungBangn-Gamisoyosan-x-gwarip |
| Gamisoyosan extract powder | Active comparator | * name of product: KyungBangn Gamisoyosan
* standard code for item: 200005591
* shape, type: powder(brown)
* usage, content: adults;three times a day each sack taken before or between meals
* dose, standard: 7.67g for each sack
* storage : airtight container, stored in room temperature
* expiration date : after manufacture 36 month
* macufacturing company: KyungBangnShinYak inc. Receives: Drug: KyungBangn Gamisoyosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 8 weeks
Symptom Checklist-90-Revised(SCL-90R)
The Symptom Checklist-90-R (SCL-90-R) is a relatively brief self-report psychometric instrument (questionnaire). It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. It is also used in measuring the progress and outcome of psychiatric and psychological treatments or for research purposes.
Measured: 8 weeks
WHO Quality of Life Abbreviated(WHOQOL-BREF)
Quality of life is used to evaluate the general well-being of individuals and societies.
Measured: 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.
Measured: 8 weeks
PSWQ
The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety
Measured: 8 weeks
GSES
The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.
Measured: 8 weeks
RSE
Rosenberg Self-Esteem Scale is questionnaire that popular lore recognizes just "high" self-esteem and "low" self-esteem, the Rosenberg Self-Esteem Scale quantify it in more detail, and feature among the most widely used systems for measuring self-esteem.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startDec 2008
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Health Industry Development Institute
- Sponsor type
- Other government
- Investigators
- In-Chul Jung, Ph.D, Principal investigator, Oriental Hospital of Daejon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285115
- Sponsor's protocol ID
- B082005
- Status last verified
- Oct 2010
- First submitted
- 26 Jan 2011
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form : A Randomized, Double Blind, Parallel-controlled Trial
- ClinicalTrials.gov ID
- NCT01285115
- Acronym / sponsor ID
- B082005
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized anxiety disorder, Jingji-zhengchong, Gamisoyosan, anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Korea Health Industry Development InstituteOther government
- Study start
- Dec 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized, double blinded, Parallel-controlled study, the investigators planned to give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of generalized anxiety disorder according to dosage form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo; corn flour, | Placebo comparator | Drug: 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, content: adults;three times a day each sack taken before or between meals * dose, standard: for each sack 7.67g * storage : airtight container, stored in room temperature * expiration date : after manufacture 36 month * macufacturing company: KyungBangnShinYak inc. |
| Gamisoyosan extract | Active comparator | Drug: KyungBangn-Gamisoyosan-x-gwarip* name of product: KyungBangn-Gamisoyosan-x-gwarip * standard code for item : 200005799 * shape, type: extract(grayish brown) * usage, content : adults;three times a day , each sack taken before or between meals * dose, standard: 7.67g for each sack * storage : airtight container, stored in room temperature expiration date : after manufacture 36 month macufacturing company: KyungBangnShinYak inc. |
| Gamisoyosan extract powder | Active comparator | Drug: KyungBangn Gamisoyosan* name of product: KyungBangn Gamisoyosan * standard code for item: 200005591 * shape, type: powder(brown) * usage, content: adults;three times a day each sack taken before or between meals * dose, standard: 7.67g for each sack * storage : airtight container, stored in room temperature * expiration date : after manufacture 36 month * macufacturing company: KyungBangnShinYak inc. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 20-65
- (Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰ) subjects who meet Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰof generalized anxiety disorder
Key exclusion criteria (8 listed)
- Currrent or past history of delusions, halucination
- 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. antianxiety drugs, antidepressant, antipsychotic drug, steroids, female hormonal drug, L-dopa, digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine) which might affect symptoms
- Medical conditions(e.g. myocardial infarction,brain tumor, multiple sclerosis, pancreatic disease, hyperthyroidism, hypothyroidism, Addison disease, Cushing disease, rheumarthritis, cancer, CVA, epilepsy, anemia, pituitarium disease, Vit B12 deficiency disease, PMS) that might affect symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks. | Drug | Placebo; corn flour, |
| KyungBangn-Gamisoyosan-x-gwaripAlso: standard code for item : 200005799AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks. | Drug | Gamisoyosan extract |
| KyungBangn GamisoyosanAlso: standard code for item: 200005591AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks. | Drug | Gamisoyosan extract powder |
Primary outcome
Hamilton Anxiety Scale(HAM-A)
Time frame: 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.
8 secondary outcomes
State-Trait Anxiety Inventory(STAI)
Time frame: 8 weeks
Beck Depression Inventory(BDI)
Time frame: 8 weeks
Symptom Checklist-90-Revised(SCL-90R)
Time frame: 8 weeks
WHO Quality of Life Abbreviated(WHOQOL-BREF)
Time frame: 8 weeks
Heart Rate Variability(HRV)
Time frame: 8 weeks
PSWQ
Time frame: 8 weeks
GSES
Time frame: 8 weeks
RSE
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Chul Jung, Ph.D principal investigator
Oriental Hospital of Daejon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KyungBangn-Gamisoyosan-x-gwarip and KyungBangn Gamisoyosan in people with Generalized Anxiety Disorder, run by Korea Health Industry Development Institute at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Scale(HAM-A) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2011.