Clinical Study on Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine
NCT ID: NCT04173832
Last Updated: 2020-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-01-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tianqi Pingchan Granule Combined With Amantadine
Tianqi Pingchan Granule Combined With Amantadine
Tianqi Pingchan Granule and Amantadine are given to patients simultaneously
placebo Combined With Amantadine
Placebo Combined With Amantadine
Placebo and Amantadine are given to patients simultaneously
Interventions
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Tianqi Pingchan Granule Combined With Amantadine
Tianqi Pingchan Granule and Amantadine are given to patients simultaneously
Placebo Combined With Amantadine
Placebo and Amantadine are given to patients simultaneously
Eligibility Criteria
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Inclusion Criteria
2. Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score ≥ 2 points;
3. 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;
4. The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment;
5. Levodopa is administered at least three times a day.
Exclusion Criteria
2. pregnant and lactating women;
3. Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment;
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. Psychiatric symptoms associated with anti-Parkinson's disease drugs
6. accompanied by a history of mental illness;
7. impaired liver and kidney function;
8. accompanied by severe other systemic diseases;
9. Amantadine treatment has been received within the first 30 days of enrollment;
10. History of medication with apomorphine or dopamine receptor antagonists;
11. Previously taking amantadine, unable to tolerate;
12. Allergic to the amantadine, memantine, and traditional Chinese medicine preparations or serious adverse reactions;
13. Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
14. has received PD-related brain surgery;
15. Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days;
16. Patients who are unable to follow up with follow-up.
30 Years
85 Years
ALL
No
Sponsors
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Shanghai University of Traditional Chinese Medicine
OTHER
Shanghai Municipal Hospital of Traditional Chinese Medicine
OTHER
Wenzhou Central Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Affiliated Hospital of Nanjing University of Chinese Medicine
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Locations
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Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yu Zhang, Doctor
Role: primary
References
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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.
Other Identifiers
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XHEC-C-2019-032-2
Identifier Type: -
Identifier Source: org_study_id