<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/NCT02192645</url>
  </required_header>
  <id_info>
    <org_study_id>SPAR</org_study_id>
    <nct_id>NCT02192645</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study</brief_title>
  <official_title>The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study (SPAR Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial Hospital of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Sanfujiu is effective and safe in the&#xD;
      treatment of persistent allergic rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial consists of 5 treatment sessions along with a one-year follow-up. This process is&#xD;
      then repeated in the second and third years. Eligible participants diagnosed with PAR were&#xD;
      randomized at a ratio of 2:2:1 into one of three groups: (a) SHP group; (b) placebo group; or&#xD;
      (c) waiting-list group. The waiting-list group will receive no treatment in the first year,&#xD;
      but will receive SHP in the following two years. The primary outcome, total nasal symptoms&#xD;
      score, is self-assessed at the beginning of each treatment session and during each annual&#xD;
      follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality of Life Questionnaire,&#xD;
      allergic rhinitis attacks, and relief medications. The trial will be stopped if early&#xD;
      termination criteria are met during the interim analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in total nasal symptom score at 12 months</measure>
    <time_frame>12 months after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months</measure>
    <time_frame>12 months after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate of Rhinitis Quality of Life Questionnaire</measure>
    <time_frame>12 months after treatment</time_frame>
    <description>Responders to study intervention are defined as patients with a change in Rhinitis Quality of Life Questionnaire score of ≥0.5 between the baseline and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of days of allergic rhinitis attack</measure>
    <time_frame>12 months after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The quantity of conventional relief medication used</measure>
    <time_frame>12 months after treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">453</enrollment>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Sanfujiu</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Formula for Sanfujiu: Huangjiezi; Xixin; Yanhusuo; and so on Acupoint for Sanfujiu: Different ten acupoints determined according to Chinese medicine theory for each time.&#xD;
Timepoint: Five times of 3 years at Sanfu Point application: The patients will be treated with herbal cake-separated moxibustion on acupoints and lasted 60 minutes each time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Formula for placebo: Fuxiaomai; and so on. the appearance is similar as drugs of Sanfujiu Acupoint for placebo: Ten acupoints determined according to Chinese medicine theory are the same as Sanfujiu group of each timepoint .&#xD;
Timepoint: Five times per year for 3 years. Point application: The patients will be treated with placebo on acupoints and lasted 60 minutes each time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>waiting list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention in the first year. Accept Sanfujiu in the second and the third years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sanfujiu</intervention_name>
    <arm_group_label>Sanfujiu</arm_group_label>
    <other_name>Sanfu-moxibustion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The placebo ointment is composed of flour, buckwheat flour, food colorants and water, resulting in an ointment similar in appearance to the Sanfujiu ointment.</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>Placebo ointment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged ≥18 with PAR, defined clinically as symptoms being present at least 4 days a&#xD;
             week, for at least 4 weeks&#xD;
&#xD;
          -  Test positive for allergen specific immunoglobulin E . Allergens include: mites&#xD;
             (Dermatophagoides pteronyssinus and Dermatophagoides farinae), cockroach (Blatella&#xD;
             germanica) and/or house dust&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  TNSS ≥3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Seasonal or chronic instance of other forms of rhinitis (i.e. sinusitis)&#xD;
&#xD;
          -  Asthma and/or moderate to severe atopic dermatitis&#xD;
&#xD;
          -  Allergy treatment at present due to asthma, eczema, atopic dermatitis, or other&#xD;
             diseases&#xD;
&#xD;
          -  Nasal structural abnormalities&#xD;
&#xD;
          -  Severe mental illness, severe chronic respiratory diseases, severe diseases of the&#xD;
             cardiovascular system, severe kidney disease, severe liver disease, severe blood&#xD;
             system diseases, severe neurological and neuromuscular disease, severe metabolic and&#xD;
             endocrine system disease, severe diabetes, immune function (including the application&#xD;
             of immunosuppressant or HIV infection to low immune function etc.); The laboratory&#xD;
             test indexes more than twice the upper limit of normal reference value or abnormal&#xD;
             results that don't fit for the study confirmed by researchers;&#xD;
&#xD;
          -  Blood coagulation dysfunction or patients are using anticoagulants&#xD;
&#xD;
          -  Systemic corticosteroids treatment six months before the start of the study, or&#xD;
             intranasal corticosteroids 15 days before the start of the study;&#xD;
&#xD;
          -  Immunotherapy for more than 3 years;&#xD;
&#xD;
          -  Alternative therapies such as acupuncture, traditional Chinese medicine (TCM) one&#xD;
             month before the start of the study,or prepare to use during the study;&#xD;
&#xD;
          -  Moxibustion therapy half years before the start of the study;&#xD;
&#xD;
          -  Patients participating other clinical trials;&#xD;
&#xD;
          -  Prepare to pregnancy, pregnancy or lactation&#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>Chuanjian Lu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangdong Provincial Hospital of Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Chuanjian Lu</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</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/NCT02192645
org study id: SPAR
nct id: NCT02192645
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether Sanfujiu is effective and safe in the
      treatment of persistent allergic rhinitis.
The trial consists of 5 treatment sessions along with a one-year follow-up. This process is
      then repeated in the second and third years. Eligible participants diagnosed with PAR were
      randomized at a ratio of 2:2:1 into one of three groups: (a) SHP group; (b) placebo group; or
      (c) waiting-list group. The waiting-list group will receive no treatment in the first year,
      but will receive SHP in the following two years. The primary outcome, total nasal symptoms
      score, is self-assessed at the beginning of each treatment session and during each annual
      follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality of Life Questionnaire,
      allergic rhinitis attacks, and relief medications. The trial will be stopped if early
      termination criteria are met during the interim analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in total nasal symptom score at 12 months
time frame: 12 months after treatment
measure: Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months
time frame: 12 months after treatment
measure: Responder rate of Rhinitis Quality of Life Questionnaire
time frame: 12 months after treatment
description: Responders to study intervention are defined as patients with a change in Rhinitis Quality of Life Questionnaire score of ≥0.5 between the baseline and 12 months
measure: The number of days of allergic rhinitis attack
time frame: 12 months after treatment
measure: The quantity of conventional relief medication used
time frame: 12 months after treatment
arm group label: Sanfujiu
arm group type: Experimental
description: Formula for Sanfujiu: Huangjiezi; Xixin; Yanhusuo; and so on Acupoint for Sanfujiu: Different ten acupoints determined according to Chinese medicine theory for each time.
Timepoint: Five times of 3 years at Sanfu Point application: The patients will be treated with herbal cake-separated moxibustion on acupoints and lasted 60 minutes each time.
arm group label: placebo
arm group type: Placebo Comparator
description: Formula for placebo: Fuxiaomai; and so on. the appearance is similar as drugs of Sanfujiu Acupoint for placebo: Ten acupoints determined according to Chinese medicine theory are the same as Sanfujiu group of each timepoint .
Timepoint: Five times per year for 3 years. Point application: The patients will be treated with placebo on acupoints and lasted 60 minutes each time.
arm group label: waiting list
arm group type: No Intervention
description: No intervention in the first year. Accept Sanfujiu in the second and the third years.
intervention type: Drug
intervention name: Sanfujiu
arm group label: Sanfujiu
other name: Sanfu-moxibustion
intervention type: Drug
intervention name: Placebo
description: The placebo ointment is composed of flour, buckwheat flour, food colorants and water, resulting in an ointment similar in appearance to the Sanfujiu ointment.
arm group label: placebo
other name: Placebo ointment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chuanjian Lu, Doctor
role: Principal Investigator
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
investigator full name: Chuanjian Lu
investigator title: Doctor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic