NCT04173845

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Levodopa-Induced Dyskinesia

Interventions

Type	Name	Description
DRUG	Tianqi Pingchan Granule	Tianqi Pingchan Granule are given twice a day
DRUG	Tianqi Pingchan Granule Placebo	Tianqi Pingchan Granule Placebo

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2019-11-22
• Last updated: 2019-11-22

Locations

1 site across 1 country: China