<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/NCT01715740</url>
  </required_header>
  <id_info>
    <org_study_id>CMRPG1B0081</org_study_id>
    <nct_id>NCT01715740</nct_id>
  </id_info>
  <brief_title>Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria</brief_title>
  <official_title>Study of the Effects of Antipruritic Chinese Herbal Medicine on Chronic Urticaria: a Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial.</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urticaria is a common dermatology disease. Urticaria affects nearly 25% of the population at&#xD;
      some time in their lives. Recurrent skin itch, insomnia, daily activities limitation greatly&#xD;
      affect the quality of life. Some patient with chronic urticaria who had poor response to&#xD;
      antihistamine may need second line medication. In United States, up to 54% chronic urticarial&#xD;
      patient use oral corticosteroid to control. However, long-term use of oral steroids still&#xD;
      needs to consider the impact of its side effects. Therefore, patients may seek for&#xD;
      alternative medicine as an adjuvant therapy.&#xD;
&#xD;
      It is still lack large-scale clinical trials in Traditional Chinese Medicine research of&#xD;
      chronic urticarial. The aim of this study is to conduct a double-blind, randomized clinical&#xD;
      trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible&#xD;
      mechanisms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditional Chinese medicine has been used widely in Taiwan for several diseases, such as&#xD;
      allergic rhinitis, atopic dermatitis. For urticaria,certain antipruritic Chinese herbal&#xD;
      medicine, such and Xiao-feng-san (XFS), Qing-shang-fang-fen-tang (QSFFT), have been commonly&#xD;
      used in clinical practice, yet no clinical trials have been done to prove the effectiveness.&#xD;
&#xD;
      In this study, a double-blinded, randomized, placebo control trial is designed and total 100&#xD;
      chronic urticaria patients will be enrolled. All subjects will be divided into Chinese herbal&#xD;
      medicine (CHM) and placebo control groups, in 1:1 allocation ratio. CHM group will receive&#xD;
      capsule of mixture of XFS and QSFFT, 4gm four times a day, total 16 gm in a single day; while&#xD;
      control group will receive placebo capsule with similar look, smell, and taste with same&#xD;
      scheme. Total 1 month treatment course with 1 month follow-up study course will be done.&#xD;
      Changes in symptom severity is the primary outcome, while improvement in sleep disturbance,&#xD;
      and serologic marker evolution are the secondary outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in symptom severity</measure>
    <time_frame>Assessment of symptom severity on starting day (day 0), day 7, day 28, day 35 and day 56 for UAS7, and the DLQI on starting day (day 0), day 28 and day 56</time_frame>
    <description>Weekly urticaria activity score (UAS7) on day 0, day 7, day 28, day 35 and day 56, and the Dermatology Life Quality Index (DLQI) on day 0, day 28, and day 56</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of sleep disturbance</measure>
    <time_frame>Assessment of insomnia (common complications with urticaria) on starting day (day 0),day 28 and day 56</time_frame>
    <description>Athens Insomnia Scale, Chinese edition (CAIS-8) is used to evaluate the improvement of sleep disturbance among chronic urticaria patient on day 0, day 28 and day 56</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of serologic markers for urticaria</measure>
    <time_frame>Assessment of changes on serum markers for urticaria on starting day (day 0), day 28 and day 56</time_frame>
    <description>Serum urticaria-related markers are checked on day 0, day 28 and day 56, including IgE, Eosinophil counts, CRP, IL-4, IL-6, IL-8, IL-10, IL-13, TNF-alpha and IFN-gamma</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Chronic Urticaria</condition>
  <arm_group>
    <arm_group_label>Chinese herbal medicine (CHM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject in CHM group will receive CHM capsules, 8 capsules (4 gm) four times a day, total 16 gm a day, combined with levocetiricine 1PC once a day for 1 month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in control group will receive the placebo capsules, which has the similar look, smell and taste. The dosage, frequency and duration are the same as CHM group, in which 8 placebo capsule (4gm) 4 times a day, total 16 gm a day, combined with levocetiricine 1PC once a day, for 1 month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chinese Herbal Medicine (CHM)</intervention_name>
    <description>Each CHM capsule, weighing 500mg, consists of XFS 250 mg and QSFFT 250 mg.</description>
    <arm_group_label>Chinese herbal medicine (CHM)</arm_group_label>
    <other_name>XFS (Xiao-feng-san):</other_name>
    <other_name>- Hsiao-feng-san</other_name>
    <other_name>- yokukansan</other_name>
    <other_name>- Eliminate Wind Powder</other_name>
    <other_name>QSFFT (Qin-shang-fang-fen-tang)</other_name>
    <other_name>- Qing-shang-fang-feng-tang</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Encapsulated powder with similar taste, color, odor to intervention Chinese herbal medicine</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as idiopathic urticaria at least 6 weeks&#xD;
&#xD;
          -  Ages from 18 to 75 years&#xD;
&#xD;
          -  Symptom severity must be above 10 points (UAS7 scoring)&#xD;
&#xD;
          -  Will to complete questionnaires and take medicine as schedule in this study&#xD;
&#xD;
          -  Volunteer for study enrollment and sign inform consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other dermatological diseases related to skin pruritus, judged by clinician&#xD;
&#xD;
          -  Systemic diseases, such as cancer, renal diseases, liver diseases, autoimmune&#xD;
             diseases, and acute infectious diseases. Judged by clinician&#xD;
&#xD;
          -  Using oral/injected steroid, leukotriene inhibitors, immuno-suppressant, or other&#xD;
             Chinese herbal medicine during one month before enrollment&#xD;
&#xD;
          -  Abnormal hemogram, liver or renal function tests in laboratory examination&#xD;
&#xD;
          -  Women who are pregnant or are planned to conceive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sien-hung Yang, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Kato S, Kato TA, Nishie H, Nishima S, Iwanaga T, Monji A, Nakano M, Takeshita H, Furue M. Successful treatment of chronic urticaria with a Japanese herbal medicine, yokukansan. J Dermatol. 2010 Dec;37(12):1066-7. doi: 10.1111/j.1346-8138.2010.00937.x. Epub 2010 Sep 29. No abstract available.</citation>
    <PMID>21083714</PMID>
  </reference>
  <reference>
    <citation>Najib U, Bajwa ZH, Ostro MG, Sheikh J. A retrospective review of clinical presentation, thyroid autoimmunity, laboratory characteristics, and therapies used in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2009 Dec;103(6):496-501. doi: 10.1016/S1081-1206(10)60266-9.</citation>
    <PMID>20084843</PMID>
  </reference>
  <reference>
    <citation>Kulthanan K, Jiamton S, Thumpimukvatana N, Pinkaew S. Chronic idiopathic urticaria: prevalence and clinical course. J Dermatol. 2007 May;34(5):294-301. doi: 10.1111/j.1346-8138.2007.00276.x.</citation>
    <PMID>17408437</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>November 9, 2016</last_update_submitted>
  <last_update_submitted_qc>November 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 10, 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>YANG SIEN-HUNG</investigator_full_name>
    <investigator_title>Director of Department of Traditional Chinese Medicine</investigator_title>
  </responsible_party>
  <keyword>Chinese herbal medicine</keyword>
  <keyword>Urticaria</keyword>
  <keyword>Antipruritics</keyword>
  <keyword>Phase III clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urticaria</mesh_term>
    <mesh_term>Chronic Urticaria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Share data should be approved by the IRB before release</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>May 10, 2017</submitted>
    <returned>October 4, 2017</returned>
  </pending_results>
  <!-- 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/NCT01715740
org study id: CMRPG1B0081
nct id: NCT01715740
lead sponsor: 
has dmc: Yes
Urticaria is a common dermatology disease. Urticaria affects nearly 25% of the population at
      some time in their lives. Recurrent skin itch, insomnia, daily activities limitation greatly
      affect the quality of life. Some patient with chronic urticaria who had poor response to
      antihistamine may need second line medication. In United States, up to 54% chronic urticarial
      patient use oral corticosteroid to control. However, long-term use of oral steroids still
      needs to consider the impact of its side effects. Therefore, patients may seek for
      alternative medicine as an adjuvant therapy.

      It is still lack large-scale clinical trials in Traditional Chinese Medicine research of
      chronic urticarial. The aim of this study is to conduct a double-blind, randomized clinical
      trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible
      mechanisms.
Traditional Chinese medicine has been used widely in Taiwan for several diseases, such as
      allergic rhinitis, atopic dermatitis. For urticaria,certain antipruritic Chinese herbal
      medicine, such and Xiao-feng-san (XFS), Qing-shang-fang-fen-tang (QSFFT), have been commonly
      used in clinical practice, yet no clinical trials have been done to prove the effectiveness.

      In this study, a double-blinded, randomized, placebo control trial is designed and total 100
      chronic urticaria patients will be enrolled. All subjects will be divided into Chinese herbal
      medicine (CHM) and placebo control groups, in 1:1 allocation ratio. CHM group will receive
      capsule of mixture of XFS and QSFFT, 4gm four times a day, total 16 gm in a single day; while
      control group will receive placebo capsule with similar look, smell, and taste with same
      scheme. Total 1 month treatment course with 1 month follow-up study course will be done.
      Changes in symptom severity is the primary outcome, while improvement in sleep disturbance,
      and serologic marker evolution are the secondary outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Changes in symptom severity
time frame: Assessment of symptom severity on starting day (day 0), day 7, day 28, day 35 and day 56 for UAS7, and the DLQI on starting day (day 0), day 28 and day 56
description: Weekly urticaria activity score (UAS7) on day 0, day 7, day 28, day 35 and day 56, and the Dermatology Life Quality Index (DLQI) on day 0, day 28, and day 56
measure: Improvement of sleep disturbance
time frame: Assessment of insomnia (common complications with urticaria) on starting day (day 0),day 28 and day 56
description: Athens Insomnia Scale, Chinese edition (CAIS-8) is used to evaluate the improvement of sleep disturbance among chronic urticaria patient on day 0, day 28 and day 56
measure: Changes of serologic markers for urticaria
time frame: Assessment of changes on serum markers for urticaria on starting day (day 0), day 28 and day 56
description: Serum urticaria-related markers are checked on day 0, day 28 and day 56, including IgE, Eosinophil counts, CRP, IL-4, IL-6, IL-8, IL-10, IL-13, TNF-alpha and IFN-gamma
arm group label: Chinese herbal medicine (CHM)
arm group type: Experimental
description: Subject in CHM group will receive CHM capsules, 8 capsules (4 gm) four times a day, total 16 gm a day, combined with levocetiricine 1PC once a day for 1 month.
arm group label: Control
arm group type: Placebo Comparator
description: Subjects in control group will receive the placebo capsules, which has the similar look, smell and taste. The dosage, frequency and duration are the same as CHM group, in which 8 placebo capsule (4gm) 4 times a day, total 16 gm a day, combined with levocetiricine 1PC once a day, for 1 month.
intervention type: Drug
intervention name: Chinese Herbal Medicine (CHM)
description: Each CHM capsule, weighing 500mg, consists of XFS 250 mg and QSFFT 250 mg.
arm group label: Chinese herbal medicine (CHM)
other name: XFS (Xiao-feng-san):
other name: - Hsiao-feng-san
other name: - yokukansan
other name: - Eliminate Wind Powder
other name: QSFFT (Qin-shang-fang-fen-tang)
other name: - Qing-shang-fang-feng-tang
intervention type: Drug
intervention name: Placebo
description: Encapsulated powder with similar taste, color, odor to intervention Chinese herbal medicine
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sien-hung Yang, Ph.D.
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
citation: Kato S, Kato TA, Nishie H, Nishima S, Iwanaga T, Monji A, Nakano M, Takeshita H, Furue M. Successful treatment of chronic urticaria with a Japanese herbal medicine, yokukansan. J Dermatol. 2010 Dec;37(12):1066-7. doi: 10.1111/j.1346-8138.2010.00937.x. Epub 2010 Sep 29. No abstract available.
PMID: 21083714
citation: Najib U, Bajwa ZH, Ostro MG, Sheikh J. A retrospective review of clinical presentation, thyroid autoimmunity, laboratory characteristics, and therapies used in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2009 Dec;103(6):496-501. doi: 10.1016/S1081-1206(10)60266-9.
PMID: 20084843
citation: Kulthanan K, Jiamton S, Thumpimukvatana N, Pinkaew S. Chronic idiopathic urticaria: prevalence and clinical course. J Dermatol. 2007 May;34(5):294-301. doi: 10.1111/j.1346-8138.2007.00276.x.
PMID: 17408437
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: YANG SIEN-HUNG
investigator title: Director of Department of Traditional Chinese Medicine
mesh term: Urticaria
mesh term: Chronic Urticaria
sharing ipd: No
ipd description: Share data should be approved by the IRB before release
submitted: May 10, 2017
returned: October 4, 2017