NCT03195231

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antidepressive Agents

Interventions

Type	Name	Description
DRUG	Wuling Powder	Patients of Wuling Group are instructed to take Wuling Powder 3 times a day and 3 pills each time for 12 weeks.
DRUG	Placebo	Patients of Placebo Group are instructed to take placebo drug 3 times a day and 3 pills each time for 12 weeks.

Timeline

• Start date: 2017-06-25
• Primary completion: 2019-12-15
• Completion: 2020-01-15
• First posted: 2017-06-22
• Last updated: 2017-06-22