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

NCT02616120 | Unknown Phase 2

• 2 other identifiers: ECPJ-BDY-2014-27SHOUFA 2014-1-4
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Herbal therapy; Parkinson's Disease; Non-motor Symptoms; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 4-week, 8-week, 12-week and 24-week.

Secondary Outcomes (2)

• changes of The Unified Parkinson's Disease Rating Scale (UPDRS) from baseline after 12-weeks treatment.

  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.

  baseline, 12-week and 24-week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

SQJZ herbal mixtures

ACTIVE COMPARATOR

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

Drug: SQJZ herbal mixtures

Interventions

SQJZ herbal mixtures DRUG

The SQJZ herbal mixtures is Chinese herb extracts. It contains Rehmannia glutinosa Libosch，Astragalus membranaceus (Fisch.) Bunge etc.( 29.375g, 2 times per day)

SQJZ herbal mixtures

Placebo DRUG

placebo contains 5%SQJZ herbal mixtures and 95% dextrin,identified to SQJZ herbal formula (29.375g, 2 times per day)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen hospital, Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• JinZhou Tian, MD,PhD

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JinZhou Tian, MD,PhD

CONTACT

jztian@hotmail.com

Jing Shi, MD

CONTACT

shijing87@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 26, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)