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

NCT01285115 | Completed Phase 3 DMC

• 1 other identifier: B082005
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized anxiety disorder; Jingji-zhengchong; Gamisoyosan; anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• State-Trait Anxiety Inventory(STAI)

  8 weeks

• Beck Depression Inventory(BDI)

  8 weeks

• Symptom Checklist-90-Revised(SCL-90R)

  8 weeks

• WHO Quality of Life Abbreviated(WHOQOL-BREF)

  8 weeks

• Heart Rate Variability(HRV)

  8 weeks

Study Arms (3)

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.

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.

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.

Drug: KyungBangn Gamisoyosan

Interventions

Placebo DRUG

AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.

Placebo; corn flour,

KyungBangn-Gamisoyosan-x-gwarip DRUG

AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.

Also known as: standard code for item : 200005799

Gamisoyosan extract

KyungBangn Gamisoyosan DRUG

AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.

Also known as: standard code for item: 200005591

Gamisoyosan extract powder

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Health Industry Development Institute: lead

Study Sites (1)

Oriental Hospital of Daejon University

Daejeon, Choong-Chung-Do, South Korea

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• In-Chul Jung, Ph.D

  Oriental Hospital of Daejon University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: December 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 27, 2011

Record last verified: 2010-10

Locations

KR (1)