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The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson's disease.
Depression as the most common non-motor comorbidity of Parkinson's disease (PD), have a negative impact on disability and quality of life.
Traditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate "Xiaoyao Pill", an antidepressant in TCM, on depression in PD.
A total of 60 patients with depression in PD will be randomized to each of the three arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental |
| |
| group 2 | Active Comparator |
| |
| group 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiaoyao Pill | Drug | herb extracts,were received two times a day for 12 weeks without dose changing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale | Change of Hamilton Depression Scale score on week 12 from baseline. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the responder rate (defined as score reduction of HAMD-17>=50%) | 12 weeks | |
| the Geriatric Depression Scale | GDS-30 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinglin Zhang, MD, PhD. | Contact | +86-10-83198677 | littlenumskull@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Piu Chan, MD. PhD. | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Recruiting | Beijing | 100053 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 30, 2013 | |
| Reset | Jan 15, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 30, 2013 | Jan 15, 2014 |
| ID | Term |
|---|---|
| D003863 | Depression |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
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| ID | Term |
|---|---|
| C516449 | xiaoyao |
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| Bupleurum+Ginkgo | Drug | herb extracts, were received two times a day for 12 weeks without dose changing. |
|
| placebo | Drug | The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing. |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |