<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/NCT02255136</url>
  </required_header>
  <id_info>
    <org_study_id>793/MBHMCH/CH/Adm/01/2011</org_study_id>
    <secondary_id>CTRI/2012/02/002419</secondary_id>
    <nct_id>NCT02255136</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Homeopathic Medicines in Treatment of Allergic Rhinitis and/or Induced Bronchial Asthma</brief_title>
  <acronym>SBRCTHILARBA</acronym>
  <official_title>An Evidence-based Single-blind Randomized Controlled Trial Searching for the Efficacy of Homoeopathic Medicines in Reducing Serum Levels of Cytokines (IL - 10, 13) and Immunoglobulin E in Allergic Rhinitis and/or Induced Bronchial Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahesh Bhattacharyya Homoeopathic Medical College and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahesh Bhattacharyya Homoeopathic Medical College and Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test whether individualized homeopathic medicines can produce&#xD;
      any significant effect beyond placebo in treatment of allergic rhinitis and/or induced&#xD;
      bronchial asthma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, single-blind (subject), randomized, placebo-controlled, parallel group,&#xD;
      interventional clinical trial is being conducted on 100 participants (subjects 50, control&#xD;
      50) suffering from allergic rhinitis and/or induced bronchial asthma since March 1, 2012 at&#xD;
      Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Government of West Bengal.&#xD;
      This trial is aimed at exploring the efficacy of homeopathic medicines in comparison with&#xD;
      placebo in reducing serum interleukin 10, 13 and immunoglobulin E measured at timeline of 1&#xD;
      year of treatment and absolute eosinophil count every 4 months up to 1 year. Matching for&#xD;
      independent and consequent variables will be done to test for bias. Parametric or&#xD;
      non-parametric tests will be employed as per distribution of data at the end of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</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>
    <intervention_model_description>Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Interleukin 10 and 13 level</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events if any</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Rhinitis; Allergic, With Asthma</condition>
  <arm_group>
    <arm_group_label>Individualized homeopathic medicines</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psorinum, Tuberculinum, Medorrhinum, Calcarea carbonica, Natrum sulphuricum etc. as indicated; Rescue medicines, e.g. Aralea racemosa, Arsenicum album, Histamine hydrochloride, House dust, Ipecacuanha, Antimonium tartaricum, Grindelia robusta etc. as indicated; 5 ml dose of indicated homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; administered twice daily for 1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5 ml dose made up of single drop of rectified spirit in 5 ml distilled water, identical in appearance of homeopathic medicine, to be administered twice daily for 1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Individualized homeopathic medicines</intervention_name>
    <description>5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year</description>
    <arm_group_label>Individualized homeopathic medicines</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water</description>
    <arm_group_label>Intervention placebo</arm_group_label>
    <other_name>Placebo: distilled water</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 5 and 65 years&#xD;
&#xD;
          -  Both sexes&#xD;
&#xD;
          -  Atopic: reactive to allergens with positive skin prick test (SPT) results and/or&#xD;
             eosinophilia&#xD;
&#xD;
          -  More than 1 year history of allergic rhinitis and/or induced bronchial asthma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nasal abnormalities causing obstruction, e.g. nasal polyp(s), deviated septum etc.&#xD;
&#xD;
          -  Previous homoeopathic immunotherapy for allergic rhinitis&#xD;
&#xD;
          -  Allergen avoidance in past 6 weeks&#xD;
&#xD;
          -  Away from usual environment for more than 1 week during trial&#xD;
&#xD;
          -  Severe asthma cases as detected clinically&#xD;
&#xD;
          -  Respiratory infection&#xD;
&#xD;
          -  Severe concomitant disease&#xD;
&#xD;
          -  Pregnancy, breast feeding, or likelihood of pregnancy&#xD;
&#xD;
          -  Oral or parenteral steroids and/or decongestant in past 6 months&#xD;
&#xD;
          -  Conventional desensitization in past 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shubhamoy Ghosh, MD(Hom)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer of the Department of Pathology &amp; Microbiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mahesh Bhattacharyya Homeopathic Medical College &amp; Hospital</name>
      <address>
        <city>Howrah</city>
        <state>West Bengal</state>
        <zip>711104</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>February 15, 2012</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>August 15, 2018</last_update_submitted>
  <last_update_submitted_qc>August 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahesh Bhattacharyya Homoeopathic Medical College and Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Shubhamoy Ghosh, MD (Hom)</investigator_full_name>
    <investigator_title>Lecturer of the Department of Pathology &amp; Microbiology</investigator_title>
  </responsible_party>
  <keyword>Interleukin</keyword>
  <keyword>Immunoglobulin</keyword>
  <keyword>Homeopathy</keyword>
  <keyword>Allergic Rhinitis</keyword>
  <keyword>Asthma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02255136
org study id: 793/MBHMCH/CH/Adm/01/2011
secondary id: CTRI/2012/02/002419
nct id: NCT02255136
lead sponsor: 
has dmc: Yes
The purpose of this study is to test whether individualized homeopathic medicines can produce
      any significant effect beyond placebo in treatment of allergic rhinitis and/or induced
      bronchial asthma
A prospective, single-blind (subject), randomized, placebo-controlled, parallel group,
      interventional clinical trial is being conducted on 100 participants (subjects 50, control
      50) suffering from allergic rhinitis and/or induced bronchial asthma since March 1, 2012 at
      Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Government of West Bengal.
      This trial is aimed at exploring the efficacy of homeopathic medicines in comparison with
      placebo in reducing serum interleukin 10, 13 and immunoglobulin E measured at timeline of 1
      year of treatment and absolute eosinophil count every 4 months up to 1 year. Matching for
      independent and consequent variables will be done to test for bias. Parametric or
      non-parametric tests will be employed as per distribution of data at the end of the trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial
primary purpose: Treatment
masking: Single (Participant)
measure: Serum Interleukin 10 and 13 level
time frame: 1 year
measure: Incidence of adverse events if any
time frame: 1 year
arm group label: Individualized homeopathic medicines
arm group type: Experimental
description: Psorinum, Tuberculinum, Medorrhinum, Calcarea carbonica, Natrum sulphuricum etc. as indicated; Rescue medicines, e.g. Aralea racemosa, Arsenicum album, Histamine hydrochloride, House dust, Ipecacuanha, Antimonium tartaricum, Grindelia robusta etc. as indicated; 5 ml dose of indicated homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; administered twice daily for 1 year
arm group label: Intervention placebo
arm group type: Placebo Comparator
description: 5 ml dose made up of single drop of rectified spirit in 5 ml distilled water, identical in appearance of homeopathic medicine, to be administered twice daily for 1 year
intervention type: Other
intervention name: Individualized homeopathic medicines
description: 5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year
arm group label: Individualized homeopathic medicines
intervention type: Other
intervention name: Placebo
description: Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water
arm group label: Intervention placebo
other name: Placebo: distilled water
criteria: 
gender: All
minimum age: 5 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shubhamoy Ghosh, MD(Hom)
role: Principal Investigator
affiliation: Lecturer of the Department of Pathology & Microbiology
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
investigator full name: Dr. Shubhamoy Ghosh, MD (Hom)
investigator title: Lecturer of the Department of Pathology & Microbiology
mesh term: Rhinitis
mesh term: Asthma
mesh term: Rhinitis, Allergic
sharing ipd: Undecided