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

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ClinicalTrials.gov Identifier: NCT03195231
Recruitment Status : Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborators:
Tongji Hospital
Shanghai Tong Ren Hospital
The First Hospital of Hebei Medical University
Information provided by (Responsible Party):
Wen Su, Beijing Hospital

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.

Condition or disease Intervention/treatment Phase
Antidepressive Agents Drug: Wuling Powder Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.
Estimated Study Start Date : June 25, 2017
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wuling Powder Group
Take Wuling Powder 3 times a day,3 pills each time for 12 weeks
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.

Placebo Comparator: Placebo Group
Take placebo drug which cannot be distinguished from the experimental drug 3 times a day,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.




Primary Outcome Measures :
  1. the change of depression from baseline to 12 weeks [ Time Frame: 12 weeks after treatment ]
    the change of depression from baseline to 12 weeks,as assessed with the use of HAMD(Hamilton Depression Scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195231


Contacts
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Contact: Xin Wang +8613661174001 wangxinannie@126.com

Sponsors and Collaborators
Beijing Hospital
Tongji Hospital
Shanghai Tong Ren Hospital
The First Hospital of Hebei Medical University
Investigators
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Principal Investigator: Wen Su Beijing Hospital

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Responsible Party: Wen Su, Clinical professor and Principal investigator, Beijing Hospital
ClinicalTrials.gov Identifier: NCT03195231     History of Changes
Other Study ID Numbers: 121-2016009
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen Su, Beijing Hospital:
Parkinson`s disease
Depression
Wuling Powder
Additional relevant MeSH terms:
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Parkinson Disease
Depression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Behavioral Symptoms