<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/NCT02208726</url>
  </required_header>
  <id_info>
    <org_study_id>KaronWillson200731900</org_study_id>
    <secondary_id>AEC44-01-2013</secondary_id>
    <nct_id>NCT02208726</nct_id>
  </id_info>
  <brief_title>The Effect of Picricum Acidum and Phosphoricum Acidum Homaccord on Perceived Levels of Anxiety in University Students</brief_title>
  <official_title>The Effect of Picricum Acidum and Phosphoricum Acidum Homaccord on Perceived Levels of Anxiety in University Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Johannesburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Johannesburg</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Increased levels of stress and anxiety are experienced by many students. Stress can have a&#xD;
      negative influence on academic outcome and performance, as well as on the student's mental&#xD;
      health. Conventional treatment options for anxiety include counseling, as well as anxiolytics&#xD;
      and antidepressants, which may have various adverse effects. Picricum acidum and Phosphoricum&#xD;
      acidum are homeopathic remedies that may be helpful in alleviating anxiety in students;&#xD;
      however there has been no research done to date to show their efficacy for this condition.&#xD;
&#xD;
      The aim of this study is to determine the effect of Picricum acidum and Phosphoricum acidum&#xD;
      Homaccord on perceived levels of anxiety in university students, by means of the&#xD;
      State-Trait-Anxiety-Inventory and Anxiety Symptom Score Card.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a randomized, double-blind, placebo-controlled study, conducted over a&#xD;
      two-week period at the University of Johannesburg (UJ) Health Clinic, Doornfontein Campus.&#xD;
      Thirty university students, aged between 18 and 45 years, will be recruited into the study by&#xD;
      means of advertisements placed on the campus with relevant permission given. Participants&#xD;
      will attend an initial consultation and will be requested to sign a Participant Information&#xD;
      and Consent form, complete the Participant Information Sheet, and a Remedy Symptom&#xD;
      Questionnaire to determine inclusion into the study. Participants' vital signs will be&#xD;
      measured. Participants will then receive a 16ml vial of either the Picricum acidum and&#xD;
      Phosphoricum acidum Homaccord pillules, or a placebo (unmedicated sucrose pillules), which&#xD;
      will be randomized and dispensed by the UJ Homeopathic Dispenser. Participants will be&#xD;
      requested to take 5 pillules in a daily dose for 14 days, commencing 21 days before and&#xD;
      ceasing 7 days prior to the start of examinations. The State-Trait-Anxiety-Inventory (STAI)&#xD;
      and the Anxiety Symptom Score Card will be completed 21 days prior to the first academic&#xD;
      examination, as well as on the last day of taking the medication. Data will be collected and&#xD;
      analyzed by Statkon, using the Shapiro-Wilk test, the Mann-Whitney test and the Wilcoxon&#xD;
      signed ranks test.&#xD;
&#xD;
      The outcome of this research may show that the Homeopathic Picricum acidum and Phosphoricum&#xD;
      acidum Homaccord has a positive effect in alleviating anxiety in university students,&#xD;
      allowing for further studies in the field.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 2</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>State-Trait-Anxiety-Inventory</measure>
    <time_frame>14 days</time_frame>
    <description>The State-Trait-Anxiety-Inventory is an established, acceptably reliable, validated and commonly utilized tool for measuring an individual's level of anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety Symptom Score Card</measure>
    <time_frame>14 days</time_frame>
    <description>The Anxiety Symptom Score Card is based on a 5-point grading scale and is designed to monitor anxiety-related symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Sucrose pillules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Unmedicated sucrose pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Homeopathic homaccord</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH. Pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sucrose pillules</intervention_name>
    <description>Unmedicated sucrose pillules</description>
    <arm_group_label>Sucrose pillules</arm_group_label>
    <other_name>Saccharum officinale</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Homeopathic homaccord</intervention_name>
    <description>Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH.</description>
    <arm_group_label>Homeopathic homaccord</arm_group_label>
    <other_name>Picricum acidum and Phosphoricum acidum homaccord</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, between the ages of 18 and 45;&#xD;
&#xD;
          -  Registered University students;&#xD;
&#xD;
          -  Participants must experience anxiety symptoms, manifesting six or more of the&#xD;
             following criteria: muscle tension, increased perspiration, rapid heartbeat,&#xD;
             headaches, stomach aches, agitation, irritability, hostility, fear, extreme&#xD;
             sensitivity to rejection or failure, motor restlessness, procrastination, excessive&#xD;
             worry, concentration difficulties, attention difficulties and memory problems;&#xD;
&#xD;
          -  Participants must be writing a major examination one week after the study ends;&#xD;
&#xD;
          -  Participants must have six or more of the symptoms relating to Picricum acidum and&#xD;
             Phosphoricum acidum (Appendix D); and&#xD;
&#xD;
          -  Participants must have a cell phone and on-line computer access.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Have been diagnosed with: A psychological anxiety disorder, Psychiatric disorders&#xD;
        (Bipolar disorder, Depression), Attention Deficit Hyperactivity Disorder and Epilepsy.&#xD;
&#xD;
          -  Are taking any chronic medication for anxiety or mood stabilizing&#xD;
&#xD;
          -  Are pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janice Pellow, M.Tech Hom</last_name>
    <role>Study Director</role>
    <affiliation>University of Johannesburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Johannesburg</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2028</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>May 16, 2016</last_update_submitted>
  <last_update_submitted_qc>May 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Johannesburg</investigator_affiliation>
    <investigator_full_name>Dr J. Pellow</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>anxiety</keyword>
  <keyword>students</keyword>
  <keyword>examinations</keyword>
  <keyword>Homeopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02208726
org study id: KaronWillson200731900
secondary id: AEC44-01-2013
nct id: NCT02208726
lead sponsor: 
has dmc: Yes
Increased levels of stress and anxiety are experienced by many students. Stress can have a
      negative influence on academic outcome and performance, as well as on the student's mental
      health. Conventional treatment options for anxiety include counseling, as well as anxiolytics
      and antidepressants, which may have various adverse effects. Picricum acidum and Phosphoricum
      acidum are homeopathic remedies that may be helpful in alleviating anxiety in students;
      however there has been no research done to date to show their efficacy for this condition.

      The aim of this study is to determine the effect of Picricum acidum and Phosphoricum acidum
      Homaccord on perceived levels of anxiety in university students, by means of the
      State-Trait-Anxiety-Inventory and Anxiety Symptom Score Card.
This study will be a randomized, double-blind, placebo-controlled study, conducted over a
      two-week period at the University of Johannesburg (UJ) Health Clinic, Doornfontein Campus.
      Thirty university students, aged between 18 and 45 years, will be recruited into the study by
      means of advertisements placed on the campus with relevant permission given. Participants
      will attend an initial consultation and will be requested to sign a Participant Information
      and Consent form, complete the Participant Information Sheet, and a Remedy Symptom
      Questionnaire to determine inclusion into the study. Participants' vital signs will be
      measured. Participants will then receive a 16ml vial of either the Picricum acidum and
      Phosphoricum acidum Homaccord pillules, or a placebo (unmedicated sucrose pillules), which
      will be randomized and dispensed by the UJ Homeopathic Dispenser. Participants will be
      requested to take 5 pillules in a daily dose for 14 days, commencing 21 days before and
      ceasing 7 days prior to the start of examinations. The State-Trait-Anxiety-Inventory (STAI)
      and the Anxiety Symptom Score Card will be completed 21 days prior to the first academic
      examination, as well as on the last day of taking the medication. Data will be collected and
      analyzed by Statkon, using the Shapiro-Wilk test, the Mann-Whitney test and the Wilcoxon
      signed ranks test.

      The outcome of this research may show that the Homeopathic Picricum acidum and Phosphoricum
      acidum Homaccord has a positive effect in alleviating anxiety in university students,
      allowing for further studies in the field.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: State-Trait-Anxiety-Inventory
time frame: 14 days
description: The State-Trait-Anxiety-Inventory is an established, acceptably reliable, validated and commonly utilized tool for measuring an individual's level of anxiety.
measure: Anxiety Symptom Score Card
time frame: 14 days
description: The Anxiety Symptom Score Card is based on a 5-point grading scale and is designed to monitor anxiety-related symptoms.
arm group label: Sucrose pillules
arm group type: Placebo Comparator
description: Unmedicated sucrose pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination.
arm group label: Homeopathic homaccord
arm group type: Experimental
description: Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH. Pillules will be taken once daily, in the morning, 30 minutes after breakfast, for 14 days, up to 7 days before the first academic examination.
intervention type: Other
intervention name: Sucrose pillules
description: Unmedicated sucrose pillules
arm group label: Sucrose pillules
other name: Saccharum officinale
intervention type: Other
intervention name: Homeopathic homaccord
description: Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH.
arm group label: Homeopathic homaccord
other name: Picricum acidum and Phosphoricum acidum homaccord
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janice Pellow, M.Tech Hom
role: Study Director
affiliation: University of Johannesburg
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of Johannesburg
investigator full name: Dr J. Pellow
investigator title: Dr
mesh term: Anxiety Disorders
sharing ipd: No