Clinical Study on Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine

Unknown 100 enrolled Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Affiliated Hospital of Nanjing University of Chinese Medicine · collab Shanghai Municipal Hospital of Traditional Chinese Medicine · collab Shanghai University of Traditional Chinese Medicine · collab The Affiliated Hospital of Qingdao University · collab The Affiliated Hospital of Xuzhou Medical University · collab Wenzhou Central Hospital · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted to observe the improvement in the level of dyskinesia in patients with Parkinson's disease during the 12-week period of oral treatment with Tianqi Pingchan Granule Combined With Amantadine. To observe the differences of the safety and effectiveness between Tianqi Pingchan Granule combined with amantadine and placebo combined with amantadine.

Timeline

Start: 2020-01-01
Primary completion: 2020-12-31
Completion: 2021-12-31

Outcome

Met primary endpoint

paper The changes in UDysRS at week 12 were -11.02 for the TPG group and -4.19 for the placebo group PMID 39060125 ↗

paper treatment difference -6.83 [-10.53 to -3.12]; P = 0.0004 PMID 39060125 ↗

Publications

Zhang Y, Zhu XB, Zhao Y, Cui GY, Li WT, Yuan CX, Huang JP, Wan Y, Wu N, Song L, Zhao JH, Liang Y, Xu CY, Liu MJ, Gao C, Chen XX, Liu ZG. Efficacy and safety of Tianqi Pingchan Granule, a compound Chinese herbal medicine, for levodopa-induced dyskinesia in Parkinson's disease: A randomized double-blind placebo-controlled trial. J Integr Med. 2024 Sep;22(5):545-551. doi: 10.1016/j.joim.2024.07.002. Epub 2024 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tianqi Pingchan Granule	Traditional medicine (herbal / TCM)	—	Oral
Background	Amantadine	Unknown	—	Oral