Clinical trial NCT02616120: Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease
Official title: Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Herbal therapy
Parkinson's Disease
Non-motor Symptoms
Randomized controlled trial
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy and safety of SQJZ Herbal Mixtures on non-motor symptoms of PD patients.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject has idiopathic Parkinson's disease with diagnostic standard of (UKPDC)
2. Subject has a Hoehn and Yahr stage score ≤4
3. Subject is male or female, ≥18 years of age，and≤80 years.
4. Subject has a total Non-Motor Symptoms Scale (NMSS) score ≥40
5. If the subject is receiving levodopa (L-DOPA),anticholinergics, monoamine oxidase (MAO) B inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the duration of the study
6. Subject agree to sign an informed consent.

Exclusion Criteria:

1. Subject is receiving therapy with anti-Parkinson's disease drugs(include levodopa (L-DOPA), amantadine, anticholinergics, monoamine oxidase (MAO) B inhibitors, dopamine receptor agonists or catechol-O-methyltransferase inhibitor),which is not under the guidance of professional doctors,either concurrently or within 28 days prior to the Baseline Visit.
2. Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, sibelium ,neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-A (MAO-A) inhibitors, methylphenidate, amphetamine.
3. Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors \[SSRIs\], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study
4. Subject has visual hallucination,and the visual hallucination happened within 1 year after been diagnosed with PD.
5. Subject has delirium。
6. Subject has Other digestive, Urological , blood system , endocrine , immune system or cardiopulmonary problems that in the view of the researchers.
7. Subject has Serum creatinine≥97umol/L；or the alanine aminotransferase(ALT) ≥40U/L;or aspartate aminotransferase≥40U/L。
8. Subject has a epilepsy history.
9. Subject has evidence of an impulse control disorder, a history of mental illness, thoughts or behaviors of suicide.
10. According to the assessment of the investigator,Subject cann't complete the study due to poor compliance, drug or Alcohol abuse.
11. Subject is participating in other clinical trials or Participated in the past 2 weeks.

Primary outcomes:
measure: changes of The Nonmotor Symptoms Scale (NMSS) from baseline after 12-weeks treatment.
timeFrame: baseline, 4-week, 8-week, 12-week and 24-week.
Secondary outcomes:
measure: changes of The Unified Parkinson's Disease Rating Scale (UPDRS) from baseline after 12-weeks treatment.
timeFrame: baseline, 4-week, 8-week, 12-week and 24-week.
measure: changes of The Parkinson's Disease Questionnaire-39 (PDQ-39) from baseline after 12-weeks treatment.
timeFrame: baseline, 12-week and 24-week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen hospital, Beijing University of Chinese Medicine
state: Beijing
Study officials:
affiliation: Dongzhimen Hospital, Beijing
name: JinZhou Tian, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: