- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04173845
Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia
November 20, 2019 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Zhenguo Liu, MD
- Phone Number: 8602125077501
- Email: zhenguoliu2004@aliyun.com
Study Contact Backup
- Name: Na Wu, MD
- Phone Number: 13524185616
- Email: nanakingkitty@163.com
Study Locations
-
-
Shanghai
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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:
- Dosage of Levodopa ≥ 400mg/d;
- Grade of H&Y≥3;
- risk score of dyskinesia>4;
Exclusion Criteria:
- PD patients with dyskinesia;
- Taking other Chinese medicines against Parkinson's disease;
- pregnant and lactating women;
Impaired cognitive function (according to pre-entry MMSE score):
secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points;
- accompanied by a history of mental illness;
- impaired liver and kidney function;
- accompanied by severe other systemic diseases;
- Previous traditional Chinese medicine preparations or serious adverse reactions
- Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
- PD related brain surgery
- Patients who are participating in other clinical studies or has participated other clinical studies within 30 days before
- 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.
Collaborators
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
Additional Relevant MeSH Terms
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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