Trial | NCT04173845  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    150
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.
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 Started
Sep 01
2019
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Nov 22
2019

Drug Tianqi Pingchan Granule Placebo

Tianqi Pingchan Granule Placebo

Drug Tianqi Pingchan Granule

Tianqi Pingchan Granule are given twice a day

Tianqi Pingchan Granule group Experimental

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 Placebo group Placebo Comparator

placebo, granule, twice a day, for six months.

Criteria 

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
No Results Posted