<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/NCT02186366</url>
  </required_header>
  <id_info>
    <org_study_id>TECF 20120210</org_study_id>
    <nct_id>NCT02186366</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type</brief_title>
  <official_title>Study of Abdominal Massage Therapy for Generalized Anxiety Disorder Based on the &quot; Essence Fosters Spirit &quot; Theory</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Qing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Generalized Anxiety Disorder (GAD) is characterized by the presence of persistent worry or&#xD;
      fear of no explicit object and fixed content, or things that might occur in real life，which&#xD;
      not corresponds with the realities. Patients with GAD may occur a series of somatic symptoms&#xD;
      including muscle tension, backaches, headaches, fatigue, insomnia, restlessness, as well as&#xD;
      psychological feelings of anxiety, worry and feeling overwhelmed. And it always brings some&#xD;
      type of functional disability or decrease in quality of life. GAD is treated by Selective&#xD;
      Serotonin Reuptake Inhibitors (SSRIs) or Serotonin, Norepinephrine Reuptake Inhibitors(SNRI)&#xD;
      and 5-ht1a receptor agonists as regular medication which have the definite effects. But, some&#xD;
      adverse reaction of SSRIs or SNRI leads to the compliance of taking medicine of patients with&#xD;
      GAD. There is an impressive data suggesting that Abdominal Massage Therapy is effective in&#xD;
      decreasing some symptoms of somatic symptoms and psychological feelings.&#xD;
&#xD;
      This study is designed as a parallel group, positive control, non-inferiority study. It will&#xD;
      recruit 140 cases of generalized anxiety disorder of deficiency of both heart and spleen&#xD;
      type. Both the treatment group and the control group will be randomly assigned 70 cases.&#xD;
      Patients in the treatment group will be treated by Abdominal Massage for 6 weeks，and the&#xD;
      control group by buspirone . The total study includes 4 views that are respectively before&#xD;
      the treatment，after 3 weeks treatment, after the whole treatment , and 3 months after the&#xD;
      whole treatment. At all of the 4 views, all participants will be estimated the scores of&#xD;
      Hamilton Depression Scale(HAMD) ,self-rating anxiety scale(SAS), and Quality of life&#xD;
      assessment scale. At the second, third and the forth views, all participants will be&#xD;
      estimated Clinical Global Impression ( CGI). At the first and the third views, all&#xD;
      participants will be collected the data of content of hydroxytryptamine（5-HT）, Norepinephrine&#xD;
      and total cortisol in blood plasma, and of blood stream speed, vascular resistance index and&#xD;
      pulsatility index of middle cerebral artery （MCA）, anterior cerebral artery（ACA）, posterior&#xD;
      cerebral artery （PCA） and basilar artery（BA）. This study aims to investigate the efficacy of&#xD;
      Abdominal Massage Therapy vs. buspirone, and discover the correlation between these scales&#xD;
      and these objective indicators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Quality control: The study site and all researchers must comply with the required&#xD;
      qualifications. All researchers must be trained before the study. The study will take a&#xD;
      number of measures to ensure the recruitment of the required sample size, and compliance of&#xD;
      intervention providers and participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>N/A</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reductive rate of Hamilton Depression Scale（ HAMD reductive rate）</measure>
    <time_frame>baseline and post- 6week intervention</time_frame>
    <description>We will estimate the scores of the Hamilton Depression Scale of participants at baseline and post- 6week intervention，then calculate the HAMD reductive rate according to the following formula：HAMD reductive rate=（scores of HAMD at baseline - scores of HAMD at post- 6week intervention ）/ scores of HAMD at baseline×100%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scores of Hamilton Depression Scale(HAMD)</measure>
    <time_frame>baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention</time_frame>
    <description>We will estimate the scores of the Hamilton Depression Scale of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of self-rating anxiety scale( SAS)</measure>
    <time_frame>baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention</time_frame>
    <description>We will estimate the scores of the self-rating anxiety scale of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of Quality of life assessment scale</measure>
    <time_frame>baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention</time_frame>
    <description>We will estimate the scores of the Quality of life assessment scale of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of Clinical Global Impression</measure>
    <time_frame>post- 3week intervention and post- 6week intervention and post-3month after 6- week intervention</time_frame>
    <description>We will estimate the scores of Clinical Global Impression.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>content of 5-HT in blood plasma</measure>
    <time_frame>baseline and post- 6week intervention</time_frame>
    <description>We will test the content of 5-HT of participants in blood plasma and record the data.</description>
  </other_outcome>
  <other_outcome>
    <measure>content of Norepinephrine in blood plasma</measure>
    <time_frame>baseline and post- 6week intervention</time_frame>
    <description>We will test the content of Norepinephrine of participants in blood plasma and record the data.</description>
  </other_outcome>
  <other_outcome>
    <measure>content of total cortisol in blood plasma</measure>
    <time_frame>baseline and post- 6week intervention</time_frame>
    <description>We will test the content of total cortisol of participants in blood plasma and record the data.</description>
  </other_outcome>
  <other_outcome>
    <measure>blood stream speed of MCA, ACA, PCA and BA</measure>
    <time_frame>baseline and post- 6week intervention</time_frame>
    <description>We will test blood stream speed of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data.</description>
  </other_outcome>
  <other_outcome>
    <measure>vascular resistance index of MCA, ACA, PCA and BA</measure>
    <time_frame>baseline and post- 6week intervention</time_frame>
    <description>We will test vascular resistance index of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data.</description>
  </other_outcome>
  <other_outcome>
    <measure>pulsatility index of MCA, ACA, PCA and BA</measure>
    <time_frame>baseline and post- 6week intervention</time_frame>
    <description>We will test pulsatility index of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Anxiety Disorders</condition>
  <arm_group>
    <arm_group_label>Abdominal Massage Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Buspirone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Buspirone by mouth 5mg three times per day for 6week</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Abdominal Massage Therapy</intervention_name>
    <description>Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early.</description>
    <arm_group_label>Buspirone</arm_group_label>
    <other_name>Abdominal Tuina Manipulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buspirone</intervention_name>
    <description>Buspirone by mouth 5mg three times per day for 6week. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early.</description>
    <arm_group_label>Abdominal Massage Therapy</arm_group_label>
    <other_name>Buspirone HCl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet criteria for a primary diagnosis of current GAD as demonstrated by a structured&#xD;
             clinical interview for Diagnostic and Statistical Manual -IV（DSM-IV）；meet a diagnosis&#xD;
             of Deficiency of both heart and spleen type.&#xD;
&#xD;
          -  The scores of SAS≥50, 24≥the scores of HAMD ≥15.&#xD;
&#xD;
          -  The symptoms of anxiety have continued not less than 6months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major depression, schizophrenia ,bipolar disease other psychotic disorders,&#xD;
             drug-dependent persons;&#xD;
&#xD;
          -  patients with severe suicidal tendencies;&#xD;
&#xD;
          -  women in pregnancy or breastfeeding, menstrual or postpartum recovery;&#xD;
&#xD;
          -  suffered from serious illness or impairment of system,such as heart and brain blood&#xD;
             vessels, lungs, liver, kidneys and blood system.&#xD;
&#xD;
          -  persons allergic to Buspirone and excipient;&#xD;
&#xD;
          -  persons suffering from epilepsy or hypertension or Glaucoma or myasthenia gravis or&#xD;
             leukopenia;&#xD;
&#xD;
          -  persons must be taking monoamine oxidase inhibitors;&#xD;
&#xD;
          -  persons who drink a lot;&#xD;
&#xD;
          -  persons with the local skin lesions in abdomen damage (such as damage, Burns, etc);&#xD;
&#xD;
          -  persons with abdominal visceral tumors, nodules, inflammation, edema, abdominal aortic&#xD;
             atherosclerosis;&#xD;
&#xD;
          -  persons without the incompetence or unable to read, write and understand&#xD;
             independently;&#xD;
&#xD;
          -  persons whom the researchers believe should not participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jennifer Gao, Master</last_name>
    <phone>022-27432929</phone>
    <phone_ext>13920595861</phone_ext>
    <email>jennifergao1982@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>James Zhang, Master</last_name>
    <phone>022-27432929</phone>
    <phone_ext>13820590796</phone_ext>
    <email>james399@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300193</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qing Sun, Bachelor</last_name>
      <phone>022-27432580</phone>
      <phone_ext>13820290606</phone_ext>
      <email>gaoshuanger111@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Sun Qing</investigator_full_name>
    <investigator_title>deputy director of the Tuina Department</investigator_title>
  </responsible_party>
  <keyword>Anxiety Disorders, Massage Therapy, Treatment Efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buspirone</mesh_term>
  </intervention_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/NCT02186366
org study id: TECF 20120210
nct id: NCT02186366
lead sponsor: 
has dmc: No
Generalized Anxiety Disorder (GAD) is characterized by the presence of persistent worry or
      fear of no explicit object and fixed content, or things that might occur in real life，which
      not corresponds with the realities. Patients with GAD may occur a series of somatic symptoms
      including muscle tension, backaches, headaches, fatigue, insomnia, restlessness, as well as
      psychological feelings of anxiety, worry and feeling overwhelmed. And it always brings some
      type of functional disability or decrease in quality of life. GAD is treated by Selective
      Serotonin Reuptake Inhibitors (SSRIs) or Serotonin, Norepinephrine Reuptake Inhibitors(SNRI)
      and 5-ht1a receptor agonists as regular medication which have the definite effects. But, some
      adverse reaction of SSRIs or SNRI leads to the compliance of taking medicine of patients with
      GAD. There is an impressive data suggesting that Abdominal Massage Therapy is effective in
      decreasing some symptoms of somatic symptoms and psychological feelings.

      This study is designed as a parallel group, positive control, non-inferiority study. It will
      recruit 140 cases of generalized anxiety disorder of deficiency of both heart and spleen
      type. Both the treatment group and the control group will be randomly assigned 70 cases.
      Patients in the treatment group will be treated by Abdominal Massage for 6 weeks，and the
      control group by buspirone . The total study includes 4 views that are respectively before
      the treatment，after 3 weeks treatment, after the whole treatment , and 3 months after the
      whole treatment. At all of the 4 views, all participants will be estimated the scores of
      Hamilton Depression Scale(HAMD) ,self-rating anxiety scale(SAS), and Quality of life
      assessment scale. At the second, third and the forth views, all participants will be
      estimated Clinical Global Impression ( CGI). At the first and the third views, all
      participants will be collected the data of content of hydroxytryptamine（5-HT）, Norepinephrine
      and total cortisol in blood plasma, and of blood stream speed, vascular resistance index and
      pulsatility index of middle cerebral artery （MCA）, anterior cerebral artery（ACA）, posterior
      cerebral artery （PCA） and basilar artery（BA）. This study aims to investigate the efficacy of
      Abdominal Massage Therapy vs. buspirone, and discover the correlation between these scales
      and these objective indicators.
Quality control: The study site and all researchers must comply with the required
      qualifications. All researchers must be trained before the study. The study will take a
      number of measures to ensure the recruitment of the required sample size, and compliance of
      intervention providers and participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: reductive rate of Hamilton Depression Scale（ HAMD reductive rate）
time frame: baseline and post- 6week intervention
description: We will estimate the scores of the Hamilton Depression Scale of participants at baseline and post- 6week intervention，then calculate the HAMD reductive rate according to the following formula：HAMD reductive rate=（scores of HAMD at baseline - scores of HAMD at post- 6week intervention ）/ scores of HAMD at baseline×100%
measure: Scores of Hamilton Depression Scale(HAMD)
time frame: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention
description: We will estimate the scores of the Hamilton Depression Scale of participants.
measure: Scores of self-rating anxiety scale( SAS)
time frame: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention
description: We will estimate the scores of the self-rating anxiety scale of participants.
measure: Scores of Quality of life assessment scale
time frame: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention
description: We will estimate the scores of the Quality of life assessment scale of participants.
measure: Scores of Clinical Global Impression
time frame: post- 3week intervention and post- 6week intervention and post-3month after 6- week intervention
description: We will estimate the scores of Clinical Global Impression.
measure: content of 5-HT in blood plasma
time frame: baseline and post- 6week intervention
description: We will test the content of 5-HT of participants in blood plasma and record the data.
measure: content of Norepinephrine in blood plasma
time frame: baseline and post- 6week intervention
description: We will test the content of Norepinephrine of participants in blood plasma and record the data.
measure: content of total cortisol in blood plasma
time frame: baseline and post- 6week intervention
description: We will test the content of total cortisol of participants in blood plasma and record the data.
measure: blood stream speed of MCA, ACA, PCA and BA
time frame: baseline and post- 6week intervention
description: We will test blood stream speed of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data.
measure: vascular resistance index of MCA, ACA, PCA and BA
time frame: baseline and post- 6week intervention
description: We will test vascular resistance index of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data.
measure: pulsatility index of MCA, ACA, PCA and BA
time frame: baseline and post- 6week intervention
description: We will test pulsatility index of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data.
arm group label: Abdominal Massage Therapy
arm group type: Experimental
description: Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks
arm group label: Buspirone
arm group type: Active Comparator
description: Buspirone by mouth 5mg three times per day for 6week
intervention type: Other
intervention name: Abdominal Massage Therapy
description: Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early.
arm group label: Buspirone
other name: Abdominal Tuina Manipulation
intervention type: Drug
intervention name: Buspirone
description: Buspirone by mouth 5mg three times per day for 6week. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early.
arm group label: Abdominal Massage Therapy
other name: Buspirone HCl
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Gao, Master
phone: 022-27432929
phone ext: 13920595861
email: jennifergao1982@126.com
last name: James Zhang, Master
phone: 022-27432929
phone ext: 13820590796
email: james399@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
investigator full name: Sun Qing
investigator title: deputy director of the Tuina Department
mesh term: Anxiety Disorders
mesh term: Buspirone