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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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ChiCTR |
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Last refreshed on:
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3 September 2018 |
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Main ID: |
ChiCTR1800018017 |
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Date of registration:
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2018-08-27 |
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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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Clinical study for the effect of the combination of Shudipingchan prescription and Monoamine oxidase inhibitor on improving early Parkinson‘s Disease symptoms and delaying the progression of the disease
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Scientific title:
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Clinical study for the effect of the combination of Shudipingchan prescription and Monoamine oxidase inhibitor on improving early Parkinson‘s Disease symptoms and delaying the progression of the disease |
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Date of first enrolment:
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2018-10-30 |
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Target sample size:
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Treatment group:92;Control group:92; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=30492 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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New Treatment Measure Clinical Study
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Countries of recruitment
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China
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Contacts
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Name:
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Canxing Yuan
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Address:
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725 Wanping Road South, Shanghai, China
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Telephone:
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+86 13611669686 |
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Email:
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ycanxing@hotmai.com |
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Affiliation:
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Longhua Hospital Shanghai University of Traditional Chinese Medicine |
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Name:
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Qing Ye
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Address:
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725 Wanping Road South, Shanghai, China
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Telephone:
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+86 13636304576 |
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Email:
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Yeqing1982889@163.com |
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Affiliation:
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Longhua Hospital Shanghai University of Traditional Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age between 30 to 85 years primary PD patient. The diagnosis was based on the MDS diagnostic criteria of 2015, [PD syndrome + no absolute exclusion criteria + > 2 supporting criteria + no warning signs (Red Flegs)];
2. Hohen-Yahr stage = 2;
3. TCM syndrome differentiation: According to TCM classification, it can be divided into liver and kidney insufficiency type, Qi and blood insufficiency type, qi stagnation and blood stasis type, phlegm-heat and wind-moving type.
Exclusion criteria: Pregnant and lactating women; patients with severe cognitive impairment or psychiatric symptoms; patients with severe liver and kidney insufficiency; patients in other clinical studies or in other clinical studies within the previous 30 days; patients unable to cooperate with the survey.
Age minimum:
30
Age maximum:
85
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's disease
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Intervention(s)
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Treatment group:Selegiline+Shudipingchan granule;Control group:Selegiline+TCM simulant;
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Primary Outcome(s)
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UPDRS;The first time adding anti PD drugs;
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Secondary Outcome(s)
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Activity of Daily Living Scale;PDQ39;
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Source(s) of Monetary Support
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Municipal Hospital emerging frontier technology joint research project
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Ethics review
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Status: Not approved
Approval date: 26/08/2013
Contact:
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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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