Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia

A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of the Prevention of Levodopa-Induced Dyskinesia With Tianqi Pingchan Granule

A randomized, double-blind, placebo-controlled multicenter clinical trial was used to observe the effectiveness, safety and side effects of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia, so as to determine the clinical efficacy of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia.

Study Overview

Detailed Description

The aim of this clinical trail is to evaluate the effect of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia in adults. All patients included in the study should meet the inclusion criteria. Half of participants will receive Tianqi Pingzhan Granule, while the other half will receive a placebo of Tianqi Pingzhan Granule. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Na Wu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with PD aged 30-85,have at least the following two conditions:

  1. Dosage of Levodopa ≥ 400mg/d;
  2. Grade of H&Y≥3;
  3. risk score of dyskinesia>4;

Exclusion Criteria:

  1. PD patients with dyskinesia;
  2. Taking other Chinese medicines against Parkinson's disease;
  3. pregnant and lactating women;
  4. Impaired cognitive function (according to pre-entry MMSE score):

    secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points;

  5. accompanied by a history of mental illness;
  6. impaired liver and kidney function;
  7. accompanied by severe other systemic diseases;
  8. Previous traditional Chinese medicine preparations or serious adverse reactions
  9. Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
  10. PD related brain surgery
  11. Patients who are participating in other clinical studies or has participated other clinical studies within 30 days before
  12. Patients unable to cooperate with the survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tianqi Pingchan Granule group
Tianqi Pingchan Granule were manufactured according to Good Manufacturing Practice (GMP) by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd. , granule, twice a day, for six months.
Tianqi Pingchan Granule are given twice a day
PLACEBO_COMPARATOR: Tianqi Pingchan Granule Placebo group
placebo, granule, twice a day, for six months.
Tianqi Pingchan Granule Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new dyskinesia attack
Time Frame: 48 weeks
The occurrence of Levodopa-Induced dyskinesia
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: 48 weeks
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Day 1 to 1 year. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impariment.
48 weeks
Patient diaries
Time Frame: 48 weeks
Change in daily "OFF"-time as assessed with patient diaries from run-in to 48 weeks. This is a self administerd diary where patients assess their motor state every half hour during 24 hours.
48 weeks
MMSE(Mini-Mental State Examination)
Time Frame: 48 weeks
To assess the degree of cognitive impairment of patients. The score range is 0-30, where a higher score means more severe cognitive impariment.
48 weeks
HAMA (Hamilton Anxiety Scale)
Time Frame: 48 weeks
To assess the severity of anxiety symptoms. The score range is 0-56, where a higher score means more severe anxiety symptoms.
48 weeks
HAMD-24(Hamilton Depression Scale-24)
Time Frame: 48 weeks
To assess the severity of depression symptoms. The score range is 0-96, where a higher score means more severe depression symptoms.
48 weeks
NMSQuest(Nonmotor symptoms Questionnaire)
Time Frame: 48 weeks
To assess the severity and frequency of non-motor symptoms of Parkinson's disease. The score range of severity and frequency is 0-90 respectively, where a higher score means more severe and frequent non-motor symptoms of Parkinson's disease.
48 weeks
PDSS (Parkinson's Disease Sleep Scale)
Time Frame: 48 weeks
To assess the severity of sleep of Parkinson's disease patients. The score range is 0-150, where a higher score means more severe sleep disorders.
48 weeks
ESS (Epwroth Sleepiness Scale)
Time Frame: 48 weeks
To assess excessive daytime sleepiness in patients with Parkinson's disease. The score range is 0-24, where a higher score means more severe sleep disorders.
48 weeks
SCOP-AUT(scale for outcomes in Parkinson's disease for autonomic symptoms)
Time Frame: 48 weeks
To assess the severity of autonomic symptoms. The score range is 0-104, where a higher score means more severe autonomic symptoms.
48 weeks
PD-ADL(Parkinson's disease-Activity of Daily Living Scale)
Time Frame: 48 weeks
To assess the severity of Daily Living activity . The score range is 0-4, where a higher score means more severe daily living activity of Parkinson's disease patients.
48 weeks
Clinical Global Impression
Time Frame: 48 weeks
Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with "no change.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Zhenguo Liu, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (ACTUAL)

November 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 20, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • XHEC-C-2019-033-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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