Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease

Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03195231

Enrollment

120

Registered

2017-06-22

Start date

2017-06-25

Completion date

2020-01-15

Last updated

2017-06-22

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

Conditions

Antidepressive Agents

Keywords

Parkinson's disease, Depression, Wuling Powder

Brief summary

Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's disease ）which may not just interfere with the motor symptoms of PD but can also cause immense personal suffering as well as decreased quality of life with increased disability and caregiver burden. However,there is little hard evidence to guide clinical treatment. Although some newer dopamine agonists also have antidepressive effect, the use of tricyclic or nontricyclic antidepressants is frequently required.However, the side-effects of these agents may also worsen some preexisting nonmotor problems in PD. Wuling powder is a Chinese medicine which is made by cultivating Xylariasp mycelium using submerged fermentation technology. Xylariasp is the fungus sclerotia which grow in termite nests. Wuling powder is mainly used to soothe nerves and anti-insomnia in clinical. The antidepressant effect of Wuling powder has been confirmed in clinical, but not in the patients of Parkinson's disease. Therefore, the investigators design a randomized, double-blind, placebo-controlled study to evaluate the antidepressant effect of Wuling powder in PD patients and its underlying mechanism.

Interventions

DRUGWuling Powder

Patients of Wuling Group are instructed to take Wuling Powder 3 times a day and 3 pills each time for 12 weeks.

DRUGPlacebo

Patients of Placebo Group are instructed to take placebo drug 3 times a day and 3 pills each time for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
the change of depression from baseline to 12 weeks	12 weeks after treatment	the change of depression from baseline to 12 weeks,as assessed with the use of HAMD（Hamilton Depression Scale）

Contacts

Primary ContactXin Wang

wangxinannie@126.com+8613661174001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026