Efficacy Study of Korean Red Ginseng to Treat Depression
This study is currently recruiting participants.
Verified December 2011 by Korea University
Sponsor:
Korea University
Collaborator:
The Korean Society of Ginseng
Information provided by (Responsible Party):
Young-Hoon Ko, Korea University
ClinicalTrials.gov Identifier:
NCT01496248
First received: December 18, 2011
Last updated: December 20, 2011
Last verified: December 2011
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Purpose
The purpose of this study is to determine whether Korean Red Ginseng are effective in the treatment of the residual symptoms of depression as an adjuvant treatment.
| Condition | Intervention |
|---|---|
|
Major Depressive Disorder |
Dietary Supplement: Korean Red Ginseng |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression |
Resource links provided by NLM:
Further study details as provided by Korea University:
Primary Outcome Measures:
- Depression Residual Symptom Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Depression Residual Symptom Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual analogue scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Visual analogue scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Mongtmery-Asberg Depression Rating Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Mongtmery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Clinical Global Index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Clinical Global Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Korean Red Ginseng |
Dietary Supplement: Korean Red Ginseng
100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder.
- Those who are in remission, which is defined as a MADRS score 8 on two consecutive visits at a 4-week interval.
- Their primary psychiatric clinician determined that they would benefit from an adjuvant treatment of Korean red ginseng for residual symptoms.
Exclusion Criteria:
- Those who have a history of substance abuse or dependence within 1 month.
- Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results.
- Those who have a past history of hypersensitivity or intolerance to Korean red ginseng.
- Those who participated in clinical trials within 1 month before entering the study entry.
- Those who are pregnant or are breast feeding.
- Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study.
- The patients unable/unlikely to comprehend/follow the protocol.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496248
Contacts
| Contact: Tae-Hee Kim | 82-31-412-5145 | thkim3125@lycos.co.kr |
Locations
| Korea, Republic of | |
| Korea University Ansan Hospital | Recruiting |
| Ansan, Gyeonggi-do, Korea, Republic of, 425-707 | |
| Contact: Tae-Hee Kim +82-31-412-5145 thkim3125@lycos.co.kr | |
| Principal Investigator: Young-Hoon Ko, M.D. | |
Sponsors and Collaborators
Korea University
The Korean Society of Ginseng
More Information
No publications provided
| Responsible Party: | Young-Hoon Ko, Associate Professor, Korea University |
| ClinicalTrials.gov Identifier: | NCT01496248 History of Changes |
| Other Study ID Numbers: | R1105721 |
| Study First Received: | December 18, 2011 |
| Last Updated: | December 20, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Korea University:
|
Major depressive disorder Residual symptoms Korean red ginseng |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013