<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/NCT02238912</url>
  </required_header>
  <id_info>
    <org_study_id>EXII(1)/29097/2011</org_study_id>
    <nct_id>NCT02238912</nct_id>
  </id_info>
  <brief_title>Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai</brief_title>
  <acronym>KR</acronym>
  <official_title>Evaluation of Preclinical Toxicity of a Siddha Formulation Kandhaga Rasayanam ( KR ) and Its Therapeutic Efficacy in Padarthamarai ( Dermatophytoses ) by an Open Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National institute of Siddha</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National institute of Siddha</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga&#xD;
      Rasayanam in Padarthamarai ( Ring worm infection )&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>skin scrapping test</measure>
    <time_frame>45 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>itching, quality of life</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>burning sensation, vanishing of lesions</measure>
    <time_frame>45 days</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied</condition>
  <arm_group>
    <arm_group_label>Kandhaga Rasayanam- single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kandhaga Rasayanam- 2grams twice a day for 45 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>kandhaga rasayanam</intervention_name>
    <description>KANDHAGA RASAYANAM is a siddha herbo mineral drug with sulphur as a sole mineral ingredient. It is chosen from the classic Siddha text Siddha Vaidhya Thirattu.</description>
    <arm_group_label>Kandhaga Rasayanam- single arm</arm_group_label>
    <other_name>Siddha herbo mineral drug KR.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients clinically diagnosed with tinea infection.&#xD;
&#xD;
          -  direct microscopy skin scraping test positive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or nursing women.&#xD;
&#xD;
          -  use of other topical or oral antifungals, immunosuppressive drugs, anthelmintic drugs&#xD;
             either currently or during 2 weeks preceeding initiation of drug trial.&#xD;
&#xD;
          -  allergy or hyperensitivity to any component of the drug.&#xD;
&#xD;
          -  clinical case of eczema, lichen planus, pityriasis versicolor, drug induced eruptions,&#xD;
             urticaria, intertrigo, tinea ungium.&#xD;
&#xD;
          -  diabetic patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National institute of siddha</name>
      <address>
        <city>Chennai</city>
        <state>Tamilnadu</state>
        <zip>600047</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://www.ctri.nic.in/</url>
    <description>TRIAL REGISTERED IN CTRI</description>
  </link>
  <reference>
    <citation>AYUSH PORTAL, GOOGLE SCHOLAR</citation>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National institute of Siddha</investigator_affiliation>
    <investigator_full_name>Dr.R.Meena</investigator_full_name>
    <investigator_title>PhD Research scholar</investigator_title>
  </responsible_party>
  <keyword>tinea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinea</mesh_term>
    <mesh_term>Tinea Pedis</mesh_term>
    <mesh_term>Tinea cruris</mesh_term>
    <mesh_term>Tinea Capitis</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/NCT02238912
org study id: EXII(1)/29097/2011
nct id: NCT02238912
lead sponsor: 
has dmc: Yes
this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga
      Rasayanam in Padarthamarai ( Ring worm infection )
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: skin scrapping test
time frame: 45 days
measure: itching, quality of life
time frame: 45 days
measure: burning sensation, vanishing of lesions
time frame: 45 days
arm group label: Kandhaga Rasayanam- single arm
arm group type: Experimental
description: Kandhaga Rasayanam- 2grams twice a day for 45 days
intervention type: Drug
intervention name: kandhaga rasayanam
description: KANDHAGA RASAYANAM is a siddha herbo mineral drug with sulphur as a sole mineral ingredient. It is chosen from the classic Siddha text Siddha Vaidhya Thirattu.
arm group label: Kandhaga Rasayanam- single arm
other name: Siddha herbo mineral drug KR.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: India
url: http://www.ctri.nic.in/
description: TRIAL REGISTERED IN CTRI
citation: AYUSH PORTAL, GOOGLE SCHOLAR
responsible party type: Principal Investigator
investigator affiliation: National institute of Siddha
investigator full name: Dr.R.Meena
investigator title: PhD Research scholar
mesh term: Tinea
mesh term: Tinea Pedis
mesh term: Tinea cruris
mesh term: Tinea Capitis