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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03195231 |
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Date of registration:
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20/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease
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Scientific title:
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Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial. |
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Date of first enrolment:
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June 25, 2017 |
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Target sample size:
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120 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03195231 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Contacts
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Name:
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Xin Wang |
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Address:
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Telephone:
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+8613661174001 |
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Email:
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wangxinannie@126.com |
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Affiliation:
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Name:
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Wen Su |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of idiopathic Parkinson`s disease according to the 2015 MDS(Movement
Disorder Society)-PD criterion
2. Hoehn-Yahr stage: 1-3
3. Under steady therapy of antiparkinsonian drugs for at least 28 days
4. HAMD=13
5. MMSE(Mini-Mental State Examination)=24
6. Neither use antidepressant drugs nor antipsychotic drugs within 4 weeks
7. Signed informed consent
Exclusion Criteria:
1. Have other psychotic symptoms
2. Suicide ideation or behavior
3. Severe cognitive impairment,chronic organs failure,malignant tumors
4. Glutamic-pyruvic transaminase or glutamic oxalacetic transaminase=1.5 times of the
high normal range or white blood cell<4*10^9/L or serum creatinine>84umol/L
5. Pregnancy or lactation period
6. Participant in other trials or have taken other experimental drugs within 90 days
7. Allergic to fungal food or fungal drugs
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Antidepressive Agents
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Intervention(s)
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Drug: Wuling Powder
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Drug: Placebo
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Primary Outcome(s)
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the change of depression from baseline to 12 weeks
[Time Frame: 12 weeks after treatment]
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Secondary ID(s)
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121-2016009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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