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A Multicenter Randomized Controlled Trial for Effect of Zishen Pingchan Granules Combined with Pramipexole in the treatment of Depression in Parkinson’s Disease

A Multicenter Randomized Controlled Trial for Effect of Zishen Pingchan Granules Combined with Pramipexole in the treatment of Depression in Parkinson’s Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019942
Enrollment
Unknown
Registered
2018-12-09
Start date
2018-12-31
Completion date
Unknown
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson’s Disease

Interventions

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

Sponsors

The Affiliated Brain Hospital of Nanjing Medical University( Nanjing Brain Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 85 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale;

Secondary

MeasureTime frame
UPDRS;PDQ-8;PDSS-2;

Countries

China

Contacts

Public ContactWeiguo Liu

The Affiliated Brain Hospital of Nanjing Medical University( Nanjing Brain Hospital)

wgliunbh@sina.com+86 13914725569

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026