<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/NCT02210377</url>
  </required_header>
  <id_info>
    <org_study_id>Chang Gung IRB 102-4749A3</org_study_id>
    <nct_id>NCT02210377</nct_id>
  </id_info>
  <brief_title>A Preliminary Randomized Study of Tianjiu (Auto-moxibustion) Effects in Patients With Intradialytic Hypotension</brief_title>
  <official_title>Department of Traditional Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intradialytic hypotension (IDH) is a most frequent complication of hemodialysis (HD) and may&#xD;
      contribute to cardiovascular events and high mortality. The etiology of IDH is&#xD;
      multifactorial; therefore, it remains a challenging problem in the management of HD patients.&#xD;
      Because moxibustion (MO) at specific points can influences hemodynamics, we hypothesize that&#xD;
      Tianjiu (auto-MO) at the traditionally used meridian points will reduce the severity of&#xD;
      hypotension in patients who undergo HD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this clinical trial, 45 patients had IDH were divided randomly into two (auto-MO therapy&#xD;
      and control) groups for 4 weeks. In the Tianjiu (auto-MO) group, the patients were applied at&#xD;
      3 points (Conception Vessel 4, and Kidney 1) for 3-4 h during HD sessions. All number of&#xD;
      episodes complicated by symptomatic IDH during HD sessions and the number of IDH-related&#xD;
      nursing interventions (Trendelenburg position, manual reduction of ultrafiltration rate,&#xD;
      infusion of isotonic saline or hypertonic fluid, lowering of dialysate temperature) in a&#xD;
      session were recorded. Pre- and post-dialysis systolic and diastolic BP, pre- and&#xD;
      post-dialysis body weights, interdialytic weight gain, percentage of target ultrafiltration&#xD;
      achieved, patient's subjective assessment of the degree of fatigue after dialysis (scale from&#xD;
      0 to 10; 0, not at all, 10, extremely) and recovery time from fatigue after dialysis were&#xD;
      measured at the 0, 2nd, 4th and 6th week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The % of target ultrafiltration achieved</measure>
    <time_frame>1 year</time_frame>
    <description>The actual ultrafiltration volume divided by the target ultrafiltration volume</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The frequency of IDH episodes and number of nursing interventions during HD sessions</measure>
    <time_frame>1 year</time_frame>
    <description>The number of IDH record and related nursing intervention during each H/D session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10)</measure>
    <time_frame>1 year</time_frame>
    <description>The improvement of subjective symptom</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' recovery time from fatigue after dialysis</measure>
    <time_frame>1 year</time_frame>
    <description>Recovery time is recorded within minutes, when arriving home, at bed time, the next morning, by next HD</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Intradialytic Hypotension</condition>
  <arm_group>
    <arm_group_label>Tianjiu (auto-moxibustion)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in the Tianjiu group will be treated with Chinese herbal patches at acupoints on the abdomen and plantar, three times per week, for 4 hours each time during HD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Tianjiu (Non auto-MO)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The participants in the control group will be given placebo patches (brown clay patches) on the same sites.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tianjiu</intervention_name>
    <description>After randomization, patients in Tianjiu and placebo (non-Tianjiu) groups will receive 12 sessions of treatment over a 4-week treatment period.The format of the Tianjiu intervention will be the same as in the treatment group. Participants will be instructed to lie supine before their HD session, and then the bilateral KI1 and CV4</description>
    <arm_group_label>Tianjiu (auto-moxibustion)</arm_group_label>
    <other_name>auto-moxibustion, herbal acupoint paste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo (non-Tianjiu)</intervention_name>
    <description>The format of the placebo (clay) intervention will be the same as in the treatment group.</description>
    <arm_group_label>Non-Tianjiu (Non auto-MO)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subjects enrolled in the study were patients undergo regular hemodialysis, ranging&#xD;
             from 20-75 years of age, at nephrologic clinic in KCGMH. These patients have&#xD;
             experienced &gt; 3 episodes of intradialytic hypotension in recent two months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1)confounding diseases such as sepsis, cancer, decompensated liver cirrhosis,&#xD;
             respiratory failure, and heart failure(NYHA&gt;3), (2) disturbed consciousness, (3)&#xD;
             pregnancy, (4) can't tolerate the heat and allergy to automoxibustion,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ming-Yen Tsai, MS</last_name>
    <email>missuriae@yahoo.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>January 28, 2016</last_update_submitted>
  <last_update_submitted_qc>January 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Ming-Yen Tsai</investigator_full_name>
    <investigator_title>Department of TCM</investigator_title>
  </responsible_party>
  <keyword>Auto-moxibusition, intra-dialytic hypotension, hemodialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Depending on the progress to decide.</ipd_description>
  </patient_data>
  <!-- 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/NCT02210377
org study id: Chang Gung IRB 102-4749A3
nct id: NCT02210377
lead sponsor: 
has dmc: No
Intradialytic hypotension (IDH) is a most frequent complication of hemodialysis (HD) and may
      contribute to cardiovascular events and high mortality. The etiology of IDH is
      multifactorial; therefore, it remains a challenging problem in the management of HD patients.
      Because moxibustion (MO) at specific points can influences hemodynamics, we hypothesize that
      Tianjiu (auto-MO) at the traditionally used meridian points will reduce the severity of
      hypotension in patients who undergo HD.
In this clinical trial, 45 patients had IDH were divided randomly into two (auto-MO therapy
      and control) groups for 4 weeks. In the Tianjiu (auto-MO) group, the patients were applied at
      3 points (Conception Vessel 4, and Kidney 1) for 3-4 h during HD sessions. All number of
      episodes complicated by symptomatic IDH during HD sessions and the number of IDH-related
      nursing interventions (Trendelenburg position, manual reduction of ultrafiltration rate,
      infusion of isotonic saline or hypertonic fluid, lowering of dialysate temperature) in a
      session were recorded. Pre- and post-dialysis systolic and diastolic BP, pre- and
      post-dialysis body weights, interdialytic weight gain, percentage of target ultrafiltration
      achieved, patient's subjective assessment of the degree of fatigue after dialysis (scale from
      0 to 10; 0, not at all, 10, extremely) and recovery time from fatigue after dialysis were
      measured at the 0, 2nd, 4th and 6th week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The % of target ultrafiltration achieved
time frame: 1 year
description: The actual ultrafiltration volume divided by the target ultrafiltration volume
measure: The frequency of IDH episodes and number of nursing interventions during HD sessions
time frame: 1 year
description: The number of IDH record and related nursing intervention during each H/D session
measure: patient's participative assessment of the degree of fatigue after dialysis (scale from 0-10)
time frame: 1 year
description: The improvement of subjective symptom
measure: Patients' recovery time from fatigue after dialysis
time frame: 1 year
description: Recovery time is recorded within minutes, when arriving home, at bed time, the next morning, by next HD
arm group label: Tianjiu (auto-moxibustion)
arm group type: Experimental
description: The participants in the Tianjiu group will be treated with Chinese herbal patches at acupoints on the abdomen and plantar, three times per week, for 4 hours each time during HD.
arm group label: Non-Tianjiu (Non auto-MO)
arm group type: Placebo Comparator
description: The participants in the control group will be given placebo patches (brown clay patches) on the same sites.
intervention type: Other
intervention name: Tianjiu
description: After randomization, patients in Tianjiu and placebo (non-Tianjiu) groups will receive 12 sessions of treatment over a 4-week treatment period.The format of the Tianjiu intervention will be the same as in the treatment group. Participants will be instructed to lie supine before their HD session, and then the bilateral KI1 and CV4
arm group label: Tianjiu (auto-moxibustion)
other name: auto-moxibustion, herbal acupoint paste
intervention type: Other
intervention name: Placebo (non-Tianjiu)
description: The format of the placebo (clay) intervention will be the same as in the treatment group.
arm group label: Non-Tianjiu (Non auto-MO)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming-Yen Tsai, MS
email: missuriae@yahoo.com.tw
facility: 
status: Recruiting
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Ming-Yen Tsai
investigator title: Department of TCM
mesh term: Hypotension
sharing ipd: Undecided
ipd description: Depending on the progress to decide.