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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2023 |
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Main ID: |
NCT02616120 |
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Date of registration:
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20/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease
ESNMS |
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Scientific title:
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Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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240 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02616120 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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JinZhou Tian, MD,PhD |
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Address:
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Telephone:
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Email:
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jztian@hotmail.com |
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Affiliation:
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Name:
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Jinzhou Tian, Ph.D |
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Address:
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Telephone:
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84013380 |
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Email:
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jztian@hotmail.com |
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Affiliation:
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Name:
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JinZhou Tian, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dongzhimen Hospital, Beijing University of Chinese Medicine |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: SQJZ herbal mixtures
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Drug: Placebo
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Primary Outcome(s)
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changes of The Nonmotor Symptoms Scale (NMSS) from baseline after 12-weeks treatment.
[Time Frame: baseline, 4-week, 8-week, 12-week and 24-week.]
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Secondary Outcome(s)
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changes of The Parkinson's Disease Questionnaire-39 (PDQ-39) from baseline after 12-weeks treatment.
[Time Frame: baseline, 12-week and 24-week]
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changes of The Unified Parkinson's Disease Rating Scale (UPDRS) from baseline after 12-weeks treatment.
[Time Frame: baseline, 4-week, 8-week, 12-week and 24-week.]
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Secondary ID(s)
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SHOUFA 2014-1-4
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ECPJ-BDY-2014-27
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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