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

  • End date
    Dec 31, 2021
  • participants needed
  • sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Updated on 27 January 2021


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.

Condition L-DOPA-Induced Dyskinesia, L-DOPA-Induced Dyskinesia, L-DOPA-Induced Dyskinesia, L-DOPA-Induced Dyskinesia
Treatment Tianqi Pingchan Granule Combined With Amantadine, Placebo Combined With Amantadine
Clinical Study IdentifierNCT04173832
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on27 January 2021


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Inclusion Criteria

PD patients between the ages of 30-85
Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score 2 points
The patient diary shows that there are at least two opening periods between 9 am and 4 pm every day, and the dyskinesia appears in the opening period, each time lasting more than half an hour
The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment
Levodopa is administered at least three times a day

Exclusion Criteria

PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia
pregnant and lactating women
Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment
Impaired cognitive function (according to pre-entry MMSE score): secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points
Psychiatric symptoms associated with anti-Parkinson's disease drugs
accompanied by a history of mental illness
impaired liver and kidney function
accompanied by severe other systemic diseases
Amantadine treatment has been received within the first 30 days of enrollment
History of medication with apomorphine or dopamine receptor antagonists
Previously taking amantadine, unable to tolerate
Allergic to the amantadine, memantine, and traditional Chinese medicine preparations or serious adverse reactions
Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention
has received PD-related brain surgery
Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days
Patients who are unable to follow up with follow-up
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