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Register:	ChiCTR
Last refreshed on:	10 December 2018
Main ID:	ChiCTR1800019942
Date of registration:	2018-12-09
Prospective Registration:	Yes
Primary sponsor:	The Affiliated Brain Hospital of Nanjing Medical University( Nanjing Brain Hospital)
Public title:	A Multicenter Randomized Controlled Trial for Effect of Zishen Pingchan Granules Combined with Pramipexole in the treatment of Depression in Parkinson’s Disease
Scientific title:	A Multicenter Randomized Controlled Trial for Effect of Zishen Pingchan Granules Combined with Pramipexole in the treatment of Depression in Parkinson’s Disease
Date of first enrolment:	2018-12-31
Target sample size:	Experimental group:150;Control group:150;
Recruitment status:	Pending
URL:	http://www.chictr.org.cn/showproj.aspx?proj=30432
Study type:	Interventional study
Study design:	Randomized parallel controlled trial
Phase:	New Treatment Measure Clinical Study

Countries of recruitment
China

Contacts

Name:	Weiguo Liu
Address:	264 Guangzhou Road, Gulou District, Nanjing, Jiangsu, China 210029
Telephone:	+86 13914725569
Email:	wgliunbh@sina.com
Affiliation:	The Affiliated Brain Hospital of Nanjing Medical University( Nanjing Brain Hospital)

Name:	Houxu Ning
Address:	264 Guangzhou Road, Gulou District, Nanjing, Jiangsu, China 210029
Telephone:	+86 13913923013
Email:	ninghouxu@126.com
Affiliation:	The Affiliated Brain Hospital of Nanjing Medical University( Nanjing Brain Hospital)

Key inclusion & exclusion criteria

Inclusion criteria: 1. men and women with aged 30-85 years and clinically evident PD;
2. Hoehn and Yahr [H&Y] stages 1-3 and HAMD-17 total score > or =8;
3. Currently taking Pramipexole with a stable dose and > or =0.75mg per day.
Exclusion criteria: 1. HAMD-17 total score <8;
2. Serious impairment of liver, kidney, heart and lung function; Deep brain stimulation history;
3. Demented PD; Pregnant woman; Women who are pregnant or breastfeeding;
4. Alcohol or drug dependence.

Age minimum: 30
Age maximum: 85
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson’s Disease

Intervention(s)

Experimental group:Zishen Pingchan Granules combined with Pramipexole;Control group:Zishen Pingchan Granules placebo combined with Pramipexole;

Primary Outcome(s)

Hamilton Depression Scale;

Secondary Outcome(s)

UPDRS;PDQ-8;PDSS-2;

Secondary ID(s)

Source(s) of Monetary Support

National Key Research and Development Program of China

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 26/08/2013
Contact:

Ying Shi

Results

Results available:
Date Posted:
Date Completed:
URL:

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