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Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson's disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson's disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.
Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: placebo | Placebo Comparator | control group patients, 40 cases |
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| Experimental: dihydroergotine mesylate sustained-release tablets | Experimental | treatment group patients, 80 cases |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo + usual care, placebo 5 mg daily; 2.5mg 2 times daily, after breakfast and dinner. |
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| Measure | Description | Time Frame |
|---|---|---|
| the objective weight of saliva in patients with Parkinson's disease changed from baseline | the objective weight of saliva in patients with Parkinson's disease changed from baseline at the 4th, 8th and 12th weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Arilliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
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| dihydroergotine mesylate sustained-release tablets | Drug | Dihydroergotine mesylate extended-release tablets + conventional treatment, dihydroergotine mesylate sustained-release tablets 5mg daily; 2.5mg 2 times daily, after breakfast and dinner. |
|