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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 31, 2020

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.

Interventions

  • Drug: Tianqi Pingchan Granule
    • Tianqi Pingchan Granule are given twice a day
  • Drug: Tianqi Pingchan Granule Placebo
    • Tianqi Pingchan Granule Placebo

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: Tianqi Pingchan Granule Placebo group
    • placebo, granule, twice a day, for six months.

Clinical Trial Outcome Measures

Primary Measures

  • new dyskinesia attack
    • Time Frame: 48 weeks
    • The occurrence of Levodopa-Induced dyskinesia

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Collaborator
    • Nanjing University of Chinese Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zhenguo Liu, MD, Principal Investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Overall Contact(s)
    • Na Wu, MD, 13524185616, nanakingkitty@163.com

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