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| Name | Class |
|---|---|
| Shanghai University of Traditional Chinese Medicine | OTHER |
| Shanghai Municipal Hospital of Traditional Chinese Medicine | OTHER |
| Wenzhou Central Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tianqi Pingchan Granule Combined With Amantadine | Experimental |
| |
| placebo Combined With Amantadine | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tianqi Pingchan Granule Combined With Amantadine | Drug | Tianqi Pingchan Granule and Amantadine are given to patients simultaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unified Dyskinesia Rating Scale (UDysRS) | The change from baseline to day 84 of treatment in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient diaries | Change in daily "OFF"-time as assessed with patient diaries from run-in to day 84. This is a self administered diary where patients assess their motor state every half hour during 24 hours. | up to 12 weeks |
| Unified Parkinson's Disease Rating Scale (MDS-UPDRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Zhang, MD | Contact | 13916006909 | zhangyu0330@126.com | |
| Zhenguo Liu, MD | Contact | 8602125077501 | zhenguoliu2004@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39060125 | Derived | 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. |
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| The Affiliated Hospital of Qingdao University |
| OTHER |
| Affiliated Hospital of Nanjing University of Chinese Medicine | OTHER |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
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| Placebo Combined With Amantadine | Drug | Placebo and Amantadine are given to patients simultaneously |
|
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Baseline (Day 1) to day 84. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment. |
| up to 12 weeks |
| Clinical Global Impression | Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with "no change | up to 12 weeks |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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