The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form

Korea Health Industry Development Institute

Status and phase: Completed; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Placebo; Drug: KyungBangn Gamisoyosan; Drug: KyungBangn-Gamisoyosan-x-gwarip

Study type: Interventional

Funder types: Other

Identifiers

NCT01285115

B082005

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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147 participants in 3 patient groups, including a placebo group

Placebo; corn flour,

Placebo Comparator group

Description:

* 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.

Treatment:

Drug: Placebo

Gamisoyosan extract

Active Comparator group

Description:

* 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.

Treatment:

Drug: KyungBangn-Gamisoyosan-x-gwarip

Gamisoyosan extract powder

Active Comparator group

Description:

* 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.

Treatment:

Drug: KyungBangn Gamisoyosan