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Efficacy and safety of Wuling capsule in the treatment of early Parkinson's disease with mild depression: a multicenter, randomized, double-blind, placebo-controlled study

Efficacy and safety of Wuling capsule in the treatment of early Parkinson's disease with mild depression: a multicenter, randomized, double-blind, placebo-controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046195
Enrollment
Unknown
Registered
2021-05-09
Start date
2021-05-10
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Parkinson's disease

Interventions

Sponsors

Xinhua Hospital, Affiliated to Shanghai Jiaotong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 45 to 80 years with primary Parkinson's disease, regardless of gender; 2.Hoehn-Yahr grading = 24 points; 4.Accompanied with depressive symptoms (8 <= HAMD17 < 18); 5.Stable basic treatment for Parkinson's disease; 6.Sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Other nervous system diseases, mental diseases and serious physical diseases; 2.History of alcohol and drug dependence; 3.Dementia patients; 4.High risk of suicide or suicide attempt within 6 months (HAMD-17 item 3 >= 3 points); 5.Antidepressant treatment or other psychotic treatment in the past month; 7.Those who participated in other clinical trials in recent 3 months; 8.Pregnant or lactating women; 9.Patients considered unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
the change of Hamilton depression scale during the treatment;

Secondary

MeasureTime frame
the change of Hamilton Anxiety Rating Scale during the treatment;the change of clinical global impression scale during the treatment;Pittsburgh Sleep Scale;

Countries

China

Contacts

Public ContactLiu Zhenguo

Xinhua Hospital, Affiliated to Shanghai JiaoTong University, School of Medicine, Shanghai, China

liuzhenguo@xinhuamed.com.cn+86 13601831431

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026