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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
placebo + usual care, placebo 5 mg daily; 2.5mg 2 times daily, after breakfast and dinner.
Dihydroergotine mesylate extended-release tablets + conventional treatment, dihydroergotine mesylate sustained-release tablets 5mg daily; 2.5mg 2 times daily, after breakfast and dinner.
The Second Arilliated Hospital of Soochow University
Suzhou, Jiangsu, China
the objective weight of saliva in patients with Parkinson's disease changed from baseline
Time frame: 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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