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

NCT ID: NCT02616120

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2023-12-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

SQJZ herbal mixtures

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

Group Type: ACTIVE_COMPARATOR

SQJZ herbal mixtures

Intervention Type: 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)

Interventions

SQJZ herbal mixtures

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

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Jinzhou Tian

vice-president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JinZhou Tian, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Locations

Dongzhimen hospital, Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

JinZhou Tian, MD,PhD

Role: CONTACT

jztian@hotmail.com

Jing Shi, MD

Role: CONTACT

shijing87@hotmail.com

Facility Contacts

Jinzhou Tian, Ph.D

Role: primary

jztian@hotmail.com

84013380

Other Identifiers

SHOUFA 2014-1-4

Identifier Type: OTHER

Identifier Source: secondary_id

ECPJ-BDY-2014-27

Identifier Type: -

Identifier Source: org_study_id