<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/NCT03838952</url>
  </required_header>
  <id_info>
    <org_study_id>2018-07-021B</org_study_id>
    <nct_id>NCT03838952</nct_id>
  </id_info>
  <brief_title>The Efficacy of Traditional Chinese Herbal Medicine for Dementia</brief_title>
  <official_title>The Efficacy of Traditional Chinese Herbal Medicine for Dementia: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The Clinical trial is a pilot study for treatment of Alzheimer dementia by traditional&#xD;
      Chinese herbal medicine(TCM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dementia is a chronic, progressive neurodegenerative syndrome, characterized by an abroad&#xD;
      category of non-reversible impairment in cerebral function, making a long-term and gradually&#xD;
      decrease in the ability to mental cognitive tasks and performance of daily activities.&#xD;
&#xD;
      The World Health Organization says that 47.5 million people around the world are living with&#xD;
      dementia. Alzheimer's disease is the most common type of dementia. Alzheimer's disease is&#xD;
      often getting worse with time, affecting memory, language, and thought.&#xD;
&#xD;
      According to the record from Ministry of Health and welfare in Taiwan. The population over 65&#xD;
      year-old is more than 3.36 million. It is estimated that there are more than 250,000 people&#xD;
      with mental disabilities, and nearly 600,000 people with mild cognitive impairment (MCI).&#xD;
      Alzheimer's disease is accounting for 60-70%, the most common type of dementia. With the&#xD;
      aging of population, experts predict that the number of patients suffering from Alzheimer's&#xD;
      disease will be up to 800,000.&#xD;
&#xD;
      In 2016, a study based on the health insurance database in Taiwan showed that 78.2% of&#xD;
      patients will take Chinese medical treatment, such as herbal medicine, acupuncture or&#xD;
      traumatology medical therapy like massage after diagnosed as Alzheimer's disease during&#xD;
      1997-2008.&#xD;
&#xD;
      The clinical trial is a pilot study. The main purpose of this study is to evaluate the&#xD;
      efficacy of traditional Chinese herbal medicine(TCM) of Alzheimer's dementia. The&#xD;
      participants diagnosed as Alzheimer's dementia will be given Traditional Chinese herbal&#xD;
      medicine powder, each pack included of Jia Wei Xiao Yao San granule(5 gm), Gou Teng granule&#xD;
      (1.1 gm),and Ba Ji Tian (1.1 gm), 2 times per day for 12 weeks. The participants will be&#xD;
      assessed by the MMSE, IADL, NPI-Q, GDS, QOL-AD, CCMQ, which will be conducted at baseline,&#xD;
      0weeks, 12weeks, and follow-up (16 weeks). To see if the traditional Chinese herbal medicine&#xD;
      can improve the symptoms of Alzheimer's dementia or its related symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 11, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of Mini-Mental State Examination(MMSE)</measure>
    <time_frame>week 0, 12, 16</time_frame>
    <description>Global cognition will be assessed by the MMSE,which will be conducted at baseline, 0weeks, 12weeks, and follow-up (16 weeks).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of Instrumental Activities of Daily Living (IADL)</measure>
    <time_frame>week 0, 12, 16</time_frame>
    <description>The instrumental activities of daily living (IADL) contains 8 items ,such as shopping, cooking, doing laundry, handling finances, using telephone, mode of transportation, responsibility for own medication and housekeeping.The IADL wil be conducted baseline, 12weeks, and follow-up (16 weeks)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of Neuropsychiatric Inventory(NPI-Q)</measure>
    <time_frame>week 0, 12, 16</time_frame>
    <description>The Neuropsychiatric Inventory Questionnaire (NPI-Q) is an informant-based instrument that measures the presence and severity of 12 Neuropsychiatric Symptoms (NPS) in patients with dementia, as well as informant distress. The NPI-Q will be conducted at baseline, 12 weeks, and follow-up (16 weeks).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of Geriatric Depression Scale (GDS)</measure>
    <time_frame>week 0, 12, 16</time_frame>
    <description>The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly, which will be conducted at baseline, 12weeks, and follow-up (16 weeks).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood test (AST/ALT/Serum Creatinine)</measure>
    <time_frame>week 0, 16</time_frame>
    <description>Check liver and kidney function through blood test at baseline, and follow-up (16 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Quality of Life-Alzheimer's Disease (QOL-AD)</measure>
    <time_frame>week 0, 12, 16</time_frame>
    <description>The Quality of Life-Alzheimer's Disease (QOL-AD) has 13-items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The QOL-AD uses straightforward language for simplicity, which will be conducted at baseline, 12 weeks, and follow-up (16 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Constitution in Chinese Medicine Questionnaire</measure>
    <time_frame>week 0, 12, 16</time_frame>
    <description>The Constitution in Chinese Medicine Questionnaire (CCMQ) consists of 60 items to classify a person into one or more of nine Body constitution(BC) types: gentleness (8 Items), Qi-deficiency (8 Items), Yang-deficiency (7 Items), Yin-deficiency (8 Items), phlegm-wetness (8 Items), wetness-heat (6 Items), blood-stasis (7 Items), Qi-depression (7 Items), and special diathesis (7 Items). Coexistence of multiple imbalanced BC types was possible which is consistent with the TCM theories. The scoring algorithm proposed in the original CCMQ was adopted in this study. A higher score in the CCMQ BC scale indicates a higher likelihood of the specific BC type, and a score of 30 is set as threshold for case definition. The CCMQ will be conducted at baseline, 12 weeks, and follow-up (16 weeks).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Dementia</condition>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Chinese herbal medicine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>drug for the subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Herbal medicine</intervention_name>
    <description>Each pack: Jia Wei Xiao Yao San granule(5 gm), Gou Teng granule (1.1 gm),and Ba Ji Tian (1.1 gm), 2 times per day for 12 weeks.</description>
    <arm_group_label>Chinese herbal medicine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosis of mild to moderate Alzheimer dementia;&#xD;
&#xD;
          2. aged over 65 years old in both gender;&#xD;
&#xD;
          3. MMSE score between 14 and 26;&#xD;
&#xD;
          4. adequate vision and hearing ability to complete all study tests;&#xD;
&#xD;
          5. with a stable caregiver.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. a medical history of other dementia types, like Frontotemporal dementia, Dementia with&#xD;
             Lewy Bodies, Vascular Dementia, and mixed type, et al;&#xD;
&#xD;
          2. known of other neurological diseases, cranial nervous system cancer&#xD;
&#xD;
          3. severe liver or kidney dysfunction (alanine aminotransferase&gt;200 IU/L, aspartate&#xD;
             transaminase&gt;200 IU/L or serum creatinine &gt;2.5 mg/dl);&#xD;
&#xD;
          4. severe cardiovascular disease (heart failure, coronary heart disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fang-Pey Chen, MD</last_name>
    <phone>+886-2-2875-7453</phone>
    <email>fpchen@vghtpe.gov.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pei-Wen Wu, MD</last_name>
    <phone>+886-2-2875-7453</phone>
    <email>tcmpww@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <contact>
      <last_name>Fang-Pey Chen, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chinese Herbal Medicine</keyword>
  <keyword>Herbal treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03838952
org study id: 2018-07-021B
nct id: NCT03838952
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Clinical trial is a pilot study for treatment of Alzheimer dementia by traditional
      Chinese herbal medicine(TCM).
Dementia is a chronic, progressive neurodegenerative syndrome, characterized by an abroad
      category of non-reversible impairment in cerebral function, making a long-term and gradually
      decrease in the ability to mental cognitive tasks and performance of daily activities.

      The World Health Organization says that 47.5 million people around the world are living with
      dementia. Alzheimer's disease is the most common type of dementia. Alzheimer's disease is
      often getting worse with time, affecting memory, language, and thought.

      According to the record from Ministry of Health and welfare in Taiwan. The population over 65
      year-old is more than 3.36 million. It is estimated that there are more than 250,000 people
      with mental disabilities, and nearly 600,000 people with mild cognitive impairment (MCI).
      Alzheimer's disease is accounting for 60-70%, the most common type of dementia. With the
      aging of population, experts predict that the number of patients suffering from Alzheimer's
      disease will be up to 800,000.

      In 2016, a study based on the health insurance database in Taiwan showed that 78.2% of
      patients will take Chinese medical treatment, such as herbal medicine, acupuncture or
      traumatology medical therapy like massage after diagnosed as Alzheimer's disease during
      1997-2008.

      The clinical trial is a pilot study. The main purpose of this study is to evaluate the
      efficacy of traditional Chinese herbal medicine(TCM) of Alzheimer's dementia. The
      participants diagnosed as Alzheimer's dementia will be given Traditional Chinese herbal
      medicine powder, each pack included of Jia Wei Xiao Yao San granule(5 gm), Gou Teng granule
      (1.1 gm),and Ba Ji Tian (1.1 gm), 2 times per day for 12 weeks. The participants will be
      assessed by the MMSE, IADL, NPI-Q, GDS, QOL-AD, CCMQ, which will be conducted at baseline,
      0weeks, 12weeks, and follow-up (16 weeks). To see if the traditional Chinese herbal medicine
      can improve the symptoms of Alzheimer's dementia or its related symptoms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes of Mini-Mental State Examination(MMSE)
time frame: week 0, 12, 16
description: Global cognition will be assessed by the MMSE,which will be conducted at baseline, 0weeks, 12weeks, and follow-up (16 weeks).
measure: Changes of Instrumental Activities of Daily Living (IADL)
time frame: week 0, 12, 16
description: The instrumental activities of daily living (IADL) contains 8 items ,such as shopping, cooking, doing laundry, handling finances, using telephone, mode of transportation, responsibility for own medication and housekeeping.The IADL wil be conducted baseline, 12weeks, and follow-up (16 weeks)
measure: Changes of Neuropsychiatric Inventory(NPI-Q)
time frame: week 0, 12, 16
description: The Neuropsychiatric Inventory Questionnaire (NPI-Q) is an informant-based instrument that measures the presence and severity of 12 Neuropsychiatric Symptoms (NPS) in patients with dementia, as well as informant distress. The NPI-Q will be conducted at baseline, 12 weeks, and follow-up (16 weeks).
measure: Changes of Geriatric Depression Scale (GDS)
time frame: week 0, 12, 16
description: The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly, which will be conducted at baseline, 12weeks, and follow-up (16 weeks).
measure: Blood test (AST/ALT/Serum Creatinine)
time frame: week 0, 16
description: Check liver and kidney function through blood test at baseline, and follow-up (16 weeks).
measure: Changes of Quality of Life-Alzheimer's Disease (QOL-AD)
time frame: week 0, 12, 16
description: The Quality of Life-Alzheimer's Disease (QOL-AD) has 13-items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The QOL-AD uses straightforward language for simplicity, which will be conducted at baseline, 12 weeks, and follow-up (16 weeks).
measure: Changes of Constitution in Chinese Medicine Questionnaire
time frame: week 0, 12, 16
description: The Constitution in Chinese Medicine Questionnaire (CCMQ) consists of 60 items to classify a person into one or more of nine Body constitution(BC) types: gentleness (8 Items), Qi-deficiency (8 Items), Yang-deficiency (7 Items), Yin-deficiency (8 Items), phlegm-wetness (8 Items), wetness-heat (6 Items), blood-stasis (7 Items), Qi-depression (7 Items), and special diathesis (7 Items). Coexistence of multiple imbalanced BC types was possible which is consistent with the TCM theories. The scoring algorithm proposed in the original CCMQ was adopted in this study. A higher score in the CCMQ BC scale indicates a higher likelihood of the specific BC type, and a score of 30 is set as threshold for case definition. The CCMQ will be conducted at baseline, 12 weeks, and follow-up (16 weeks).
arm group label: Chinese herbal medicine group
arm group type: Experimental
description: drug for the subjects
intervention type: Drug
intervention name: Herbal medicine
description: Each pack: Jia Wei Xiao Yao San granule(5 gm), Gou Teng granule (1.1 gm),and Ba Ji Tian (1.1 gm), 2 times per day for 12 weeks.
arm group label: Chinese herbal medicine group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Fang-Pey Chen, MD
phone: +886-2-2875-7453
email: fpchen@vghtpe.gov.tw
last name: Pei-Wen Wu, MD
phone: +886-2-2875-7453
email: tcmpww@gmail.com
facility: 
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia