A randomized, double-blind, placebo-controlled multicenter clinical trial was used to observe the effectiveness, safety and side effects of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia, so as to determine the clinical efficacy of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia.
The aim of this clinical trail is to evaluate the effect of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia in adults. All patients included in the study should meet the inclusion criteria. Half of participants will receive Tianqi Pingzhan Granule, while the other half will receive a placebo of Tianqi Pingzhan Granule. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
150
Tianqi Pingchan Granule are given twice a day
Tianqi Pingchan Granule Placebo
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGnew dyskinesia attack
The occurrence of Levodopa-Induced dyskinesia
Time frame: 48 weeks
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Day 1 to 1 year. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impariment.
Time frame: 48 weeks
Patient diaries
Change in daily "OFF"-time as assessed with patient diaries from run-in to 48 weeks. This is a self administerd diary where patients assess their motor state every half hour during 24 hours.
Time frame: 48 weeks
MMSE（Mini-Mental State Examination）
To assess the degree of cognitive impairment of patients. The score range is 0-30, where a higher score means more severe cognitive impariment.
Time frame: 48 weeks
HAMA (Hamilton Anxiety Scale)
To assess the severity of anxiety symptoms. The score range is 0-56, where a higher score means more severe anxiety symptoms.
Time frame: 48 weeks
HAMD-24(Hamilton Depression Scale-24)
To assess the severity of depression symptoms. The score range is 0-96, where a higher score means more severe depression symptoms.
Time frame: 48 weeks
NMSQuest（Nonmotor symptoms Questionnaire）
To assess the severity and frequency of non-motor symptoms of Parkinson's disease. The score range of severity and frequency is 0-90 respectively, where a higher score means more severe and frequent non-motor symptoms of Parkinson's disease.
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Time frame: 48 weeks
PDSS （Parkinson's Disease Sleep Scale）
To assess the severity of sleep of Parkinson's disease patients. The score range is 0-150, where a higher score means more severe sleep disorders.
Time frame: 48 weeks
ESS （Epwroth Sleepiness Scale）
To assess excessive daytime sleepiness in patients with Parkinson's disease. The score range is 0-24, where a higher score means more severe sleep disorders.
Time frame: 48 weeks
SCOP-AUT(scale for outcomes in Parkinson's disease for autonomic symptoms)
To assess the severity of autonomic symptoms. The score range is 0-104, where a higher score means more severe autonomic symptoms.
Time frame: 48 weeks
PD-ADL（Parkinson's disease-Activity of Daily Living Scale）
To assess the severity of Daily Living activity . The score range is 0-4, where a higher score means more severe daily living activity of Parkinson's disease patients.
Time frame: 48 weeks
Clinical Global Impression
Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with "no change.
Time frame: 48 weeks