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Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease (ESNMS)

Primary Purpose

Parkinson's Disease

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SQJZ herbal mixtures
Placebo
Sponsored by
Dongzhimen Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Herbal therapy, Parkinson's Disease, Non-motor Symptoms, Randomized controlled trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dongzhimen hospital, Beijing University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

SQJZ herbal mixtures

Arm Description

placebo identified to SQJZ herbal mixtures, 29.375g, 2 times per day.for 12 weeks.

SQJZ herbal mixtures 29.375g, 2 times per day.for 12 weeks.

Outcomes

Primary Outcome Measures

changes 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.

Secondary Outcome Measures

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.
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').

Full Information

First Posted
November 20, 2015
Last Updated
February 18, 2023
Sponsor
Dongzhimen Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02616120
Brief Title
Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease
Acronym
ESNMS
Official Title
Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Herbal therapy, Parkinson's Disease, Non-motor Symptoms, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo identified to SQJZ herbal mixtures, 29.375g, 2 times per day.for 12 weeks.
Arm Title
SQJZ herbal mixtures
Arm Type
Active Comparator
Arm Description
SQJZ herbal mixtures 29.375g, 2 times per day.for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
SQJZ herbal mixtures
Intervention Description
The SQJZ herbal mixtures is Chinese herb extracts. It contains Rehmannia glutinosa Libosch，Astragalus membranaceus (Fisch.) Bunge etc.( 29.375g, 2 times per day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo contains 5%SQJZ herbal mixtures and 95% dextrin,identified to SQJZ herbal formula (29.375g, 2 times per day)
Primary Outcome Measure Information:
Title
changes of The Nonmotor Symptoms Scale (NMSS) from baseline after 12-weeks treatment.
Description
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.
Secondary Outcome Measure Information:
Title
changes of The Unified Parkinson's Disease Rating Scale (UPDRS) from baseline after 12-weeks treatment.
Description
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.
Title
changes of The Parkinson's Disease Questionnaire-39 (PDQ-39) from baseline after 12-weeks treatment.
Description
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').
Time Frame
baseline, 12-week and 24-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has idiopathic Parkinson's disease with diagnostic standard of (UKPDC) Subject has a Hoehn and Yahr stage score ≤4 Subject is male or female, ≥18 years of age，and≤80 years. Subject has a total Non-Motor Symptoms Scale (NMSS) score ≥40 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 Subject agree to sign an informed consent. Exclusion Criteria: 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. 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. 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 Subject has visual hallucination,and the visual hallucination happened within 1 year after been diagnosed with PD. Subject has delirium。 Subject has Other digestive, Urological , blood system , endocrine , immune system or cardiopulmonary problems that in the view of the researchers. Subject has Serum creatinine≥97umol/L；or the alanine aminotransferase(ALT) ≥40U/L;or aspartate aminotransferase≥40U/L。 Subject has a epilepsy history. Subject has evidence of an impulse control disorder, a history of mental illness, thoughts or behaviors of suicide. According to the assessment of the investigator,Subject cann't complete the study due to poor compliance, drug or Alcohol abuse. Subject is participating in other clinical trials or Participated in the past 2 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JinZhou Tian, MD,PhD
Email
jztian@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Shi, MD
Email
shijing87@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JinZhou Tian, MD,PhD
Organizational Affiliation
Dongzhimen Hospital, Beijing University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongzhimen hospital, Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinzhou Tian, Ph.D
Phone
84013380
Email
jztian@hotmail.com

12. IPD Sharing Statement

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Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease

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