The purpose of this study is to examine the efficacy and safety of SQJZ Herbal Mixtures on non-motor symptoms of PD patients.
This will be a multicentre, double-blind, placebo-controlled, parallel-group trial. Patients will be randomly assigned via an random number table to either the SQJZ herbal mixtures or placebo in a 2:1 ratio. Randomization will be stratify by age and gender. All participants are asked to maintain the regular medication schedule during the 12-week intervention. Assessments are conducted prior to the intervention and at 4-week, 8-week and 12-week directly after the intervention. Also, long-term effects will be assessed at 24 weeks of follow-up (from post-enrolment). The assessments will be performed by a blinded investigator who is not involved in the randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
The SQJZ herbal mixtures is Chinese herb extracts. It contains Rehmannia glutinosa Libosch,Astragalus membranaceus (Fisch.) Bunge etc.( 29.375g, 2 times per day)
placebo contains 5%SQJZ herbal mixtures and 95% dextrin,identified to SQJZ herbal formula (29.375g, 2 times per day)
Dongzhimen hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
RECRUITINGchanges of The Nonmotor Symptoms Scale (NMSS) from baseline after 12-weeks treatment.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent \[daily or all the time\]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The NMSS was assessed at introduction period, baseline, 4-week, 8-week, 12-week and 24-week.
Time frame: baseline, 4-week, 8-week, 12-week and 24-week.
changes of The Unified Parkinson's Disease Rating Scale (UPDRS) from baseline after 12-weeks treatment.
This questionnaire is a scale for the assessment of function in Parkinson's Disease.It is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.
Time frame: baseline, 4-week, 8-week, 12-week and 24-week.
changes of The Parkinson's Disease Questionnaire-39 (PDQ-39) from baseline after 12-weeks treatment.
This questionnaire is a measure of quality of life adapted for people with PD . It consists of 39 statements that cover eight domains associated with health, such as mobility and emotionality, that can be influenced by PD. Patients can reply by ticking the relevant answer that indicates whether they experienced problems during the past month (five boxes from 'never' to 'always').
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Time frame: baseline, 12-week and 24-week