xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06035913</url>
    </required_header>
    <id_info>
      <org_study_id>KY20230829-01</org_study_id>
      <nct_id>NCT06035913</nct_id>
    </id_info>
    <brief_title>Mid-and Long-term Efficacy of Ergot Alkaloids in the Treatment of Salivation in Patients With Parkinson's Disease.</brief_title>
    <official_title>Doctor of Medicine, Chief Physician, Associate Professor, Master Supervisor, Administrative Deputy Director of Neurology.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanjing First Hospital, Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanjing First Hospital, Nanjing Medical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's&#xD;
        disease, the incidence of population over 60 years old in China is 1.37%, Parkinson's disease&#xD;
        is often accompanied by various non-motor symptoms, such as salivation. Salivation can occur&#xD;
        at any time in Parkinson's disease, with an incidence of 32% to 74%, often leading to social&#xD;
        embarrassment, skin infections, bad breath, aspiration pneumonia, etc. This not only reduces&#xD;
        the quality of life of patients, but also increases the burden on caregivers. Salivation can&#xD;
        improve symptoms with botulinum toxin injections, medications, and non-drug treatments.&#xD;
        Dihydroergot mesylate has been shown to be effective in the treatment of salivation in&#xD;
        patients with Parkinson's disease, and this study will further observe the medium- to&#xD;
        long-term efficacy of the drug on salivation symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of the study is to further observe the medium- and long-term efficacy and&#xD;
        adverse reactions of the drug on the basis of the proven effectiveness of dihydroergot&#xD;
        mesylate sustained-release tablets on salivation symptoms in patients with Parkinson's&#xD;
        disease, and to evaluate the effect of the drug on swallowing function and cognitive function&#xD;
        of patients and explore its possible mechanism of action. The study was based on a scale&#xD;
        assessment of identified cases, and at the identified endpoints, the primary outcome was set&#xD;
        as improvement in SCS-PD scale scores after March, and secondary outcomes were set as disease&#xD;
        progression since March (as demonstrated by MDS-UPDRS Part III scale scores), changes in&#xD;
        swallowing function, cognitive function, liver and kidney function indicators, and adverse&#xD;
        effects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Improvement of the SCS-PD scale</measure>
      <time_frame>6 months</time_frame>
      <description>Improvement in salivation was assessed by the change in scores on the SCS-PD scale</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Main Heading (Descriptor) Terms</condition>
    <arm_group>
      <arm_group_label>Salivation group</arm_group_label>
      <description>The saliva group was instructed to take dihydroergot mesylate, one tablet twice a day, and observed the improvement of salivation after 1 week, after 1 month, after March and after 6 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dihydroergot mesylate</intervention_name>
      <description>take medicine</description>
      <arm_group_label>Salivation group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who meet the diagnostic criteria for Parkinson's disease and have varying degrees&#xD;
          of salivation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Age: Adult (≥ 18 years) Gender: male or female All patients met the British Parkinson's&#xD;
          Association Brain Bank criteria for the clinical diagnosis of primary Parkinson's disease&#xD;
          Patients had mild, moderate, to severe salivation (MDS-UPDRS-IL-2 score≥ 2) There has been&#xD;
          no drug adjustment in the past 3 months Voluntarily sign an informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Secondary PD or Parkinson's superposition syndrome Those with severe cognitive impairment,&#xD;
          speech impairment, dysarthria, and deafness who cannot cooperate with the completion of the&#xD;
          examination History of previous drug allergy Have a condition other than Parkinson's&#xD;
          disease that can cause severe salivation or other oral and glandular problems In the past 3&#xD;
          months, botulinum toxin, anticholinergic drugs, etc. have been used to treat salivation&#xD;
          symptoms Severe cardiopulmonary diseases, tumors, liver and kidney diseases and other&#xD;
          chronic wasting diseases People with mental disorders No previous history of dysphagia or&#xD;
          salivation due to cerebral infarction or other causes Those who do not cooperate with the&#xD;
          test requirements process and follow-up Those who had poor medication adherence during the&#xD;
          study, including alcohol abuse and drug dependence Subjects enrolled in clinical trials of&#xD;
          other drugs within 3 months Severe orthostatic hypotension and bradycardia and organic&#xD;
          lesions of the heart, decreased renal function Subjects who the investigators consider&#xD;
          unsuitable for clinical trials for other reasons&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Youyong Tian</last_name>
      <role>Study Director</role>
      <affiliation>Chief physician</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Dihydroergot mesylate</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06035913
  org study id: KY20230829-01
  nct id: NCT06035913
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's
        disease, the incidence of population over 60 years old in China is 1.37%, Parkinson's disease
        is often accompanied by various non-motor symptoms, such as salivation. Salivation can occur
        at any time in Parkinson's disease, with an incidence of 32% to 74%, often leading to social
        embarrassment, skin infections, bad breath, aspiration pneumonia, etc. This not only reduces
        the quality of life of patients, but also increases the burden on caregivers. Salivation can
        improve symptoms with botulinum toxin injections, medications, and non-drug treatments.
        Dihydroergot mesylate has been shown to be effective in the treatment of salivation in
        patients with Parkinson's disease, and this study will further observe the medium- to
        long-term efficacy of the drug on salivation symptoms.
  The objective of the study is to further observe the medium- and long-term efficacy and
        adverse reactions of the drug on the basis of the proven effectiveness of dihydroergot
        mesylate sustained-release tablets on salivation symptoms in patients with Parkinson's
        disease, and to evaluate the effect of the drug on swallowing function and cognitive function
        of patients and explore its possible mechanism of action. The study was based on a scale
        assessment of identified cases, and at the identified endpoints, the primary outcome was set
        as improvement in SCS-PD scale scores after March, and secondary outcomes were set as disease
        progression since March (as demonstrated by MDS-UPDRS Part III scale scores), changes in
        swallowing function, cognitive function, liver and kidney function indicators, and adverse
        effects.
  observational model: Other
  time perspective: Prospective
  measure: Improvement of the SCS-PD scale
  time frame: 6 months
  description: Improvement in salivation was assessed by the change in scores on the SCS-PD scale
  arm group label: Salivation group
  description: The saliva group was instructed to take dihydroergot mesylate, one tablet twice a day, and observed the improvement of salivation after 1 week, after 1 month, after March and after 6 months.
  intervention type: Drug
  intervention name: Dihydroergot mesylate
  description: take medicine
  arm group label: Salivation group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Youyong Tian
  role: Study Director
  affiliation: Chief physician
  facility: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No