<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/NCT02981147</url>
  </required_header>
  <id_info>
    <org_study_id>PE/PK/PYTUS/SP/2017-01</org_study_id>
    <nct_id>NCT02981147</nct_id>
  </id_info>
  <brief_title>PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough</brief_title>
  <acronym>PEACe</acronym>
  <official_title>PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PharmEvo Pvt Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PharmEvo Pvt Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy of Phytus in Acute Cough&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Common colds are the most frequently encountered human diseases worldwide. Common cold is a&#xD;
      conventional term used for mild upper respiratory illnesses, which comprises a heterogeneous&#xD;
      group of self-limited diseases caused by numerous viruses. The frequency is age-specific with&#xD;
      fewer episodes in adults than in younger children. Cough due to the common cold is probably&#xD;
      the most common cause of acute cough. In a significant subset of patients with &quot;post&#xD;
      infectious&quot; cough, the etiology is probably an inflammatory response triggered by a viral&#xD;
      upper respiratory infection (ie, the common cold). The resultant sub-acute or chronic cough&#xD;
      can be considered to be due to an upper airway cough syndrome, previously referred to as&#xD;
      postnasal drip syndrome.&#xD;
&#xD;
      Thyme leaf (Thymus vulgaris) expels phlegm and relieves congestion . It is antiseptic and an&#xD;
      immune stimulant. The primary chemical constituents of Thyme include essential oil (borneol,&#xD;
      carvacrol, cymol, linalool, thymol), bitter principle, tannin, flavonoids (apigenin,&#xD;
      luteolin), saponins, and triterpenic acids. Thyme warms and stimulates the lungs, expels&#xD;
      mucus, and relieves congestion. It also helps deter bacterial, fungal, and viral infections.&#xD;
      The thymol content of thyme works as an expectorant and cough suppressant and is frequently&#xD;
      used in cough syrups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2017</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</primary_completion_date>
  <phase>Phase 4</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>Change in day cough score at end of study</measure>
    <time_frame>4 nights (onset of trial Night 1 to Night 4)</time_frame>
    <description>A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in night cough score at end of study</measure>
    <time_frame>4 nights (onset of trial Night 1 to Night 4)</time_frame>
    <description>A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the past night. The scale rates each parameter from 0 (not at all) to 6 (extremely).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Cough</condition>
  <condition>Common Cold</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phytus (Cisti, thyme and Ivy leaves) given to patients on day 1 and day 4. On 4th day, night and day cough score along with adverse event will be assessed. Sponsor will bear the treatment cost during the study time period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phytus (Cisti, Thyme and Ivy Leaves)</intervention_name>
    <description>Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>herbal medicine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cough attributed to URTI such as the common cold&#xD;
&#xD;
          -  Moderate to severe day cough according to questionnaire (score at least 3 on all 3&#xD;
             questions relating to day cough) considering the day prior to enrollment.&#xD;
&#xD;
          -  Moderate to severe night cough score according to questionnaire (score at least 3 of 2&#xD;
             of the three questions relating to the evaluation of nocturnal cough&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic cardiac condition, or cystic fibrosis or any anatomical&#xD;
             respiratory tract anomalies,&#xD;
&#xD;
          -  Received antihistamines or any cough medicine the day prior to study entry,Known&#xD;
             sensitivity to any component of Phytus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Masood Jawaid, MRCS,FCPS</last_name>
    <role>Study Director</role>
    <affiliation>PharmEvo Pvt Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KCHS Medical Center 1st Floor, Tipu Sultan Road.</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>July 6, 2018</last_update_submitted>
  <last_update_submitted_qc>July 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cough</keyword>
  <keyword>thyme</keyword>
  <keyword>Cisti</keyword>
  <keyword>Ivy Leaves</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Common Cold</mesh_term>
    <mesh_term>Cough</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/NCT02981147
org study id: PE/PK/PYTUS/SP/2017-01
nct id: NCT02981147
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the efficacy of Phytus in Acute Cough
Common colds are the most frequently encountered human diseases worldwide. Common cold is a
      conventional term used for mild upper respiratory illnesses, which comprises a heterogeneous
      group of self-limited diseases caused by numerous viruses. The frequency is age-specific with
      fewer episodes in adults than in younger children. Cough due to the common cold is probably
      the most common cause of acute cough. In a significant subset of patients with "post
      infectious" cough, the etiology is probably an inflammatory response triggered by a viral
      upper respiratory infection (ie, the common cold). The resultant sub-acute or chronic cough
      can be considered to be due to an upper airway cough syndrome, previously referred to as
      postnasal drip syndrome.

      Thyme leaf (Thymus vulgaris) expels phlegm and relieves congestion . It is antiseptic and an
      immune stimulant. The primary chemical constituents of Thyme include essential oil (borneol,
      carvacrol, cymol, linalool, thymol), bitter principle, tannin, flavonoids (apigenin,
      luteolin), saponins, and triterpenic acids. Thyme warms and stimulates the lungs, expels
      mucus, and relieves congestion. It also helps deter bacterial, fungal, and viral infections.
      The thymol content of thyme works as an expectorant and cough suppressant and is frequently
      used in cough syrups.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in day cough score at end of study
time frame: 4 nights (onset of trial Night 1 to Night 4)
description: A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely)
measure: Change in night cough score at end of study
time frame: 4 nights (onset of trial Night 1 to Night 4)
description: A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the past night. The scale rates each parameter from 0 (not at all) to 6 (extremely).
arm group label: Intervention
arm group type: Experimental
description: Phytus (Cisti, thyme and Ivy leaves) given to patients on day 1 and day 4. On 4th day, night and day cough score along with adverse event will be assessed. Sponsor will bear the treatment cost during the study time period.
intervention type: Drug
intervention name: Phytus (Cisti, Thyme and Ivy Leaves)
description: Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.
arm group label: Intervention
other name: herbal medicine
criteria: 
gender: All
minimum age: 2 Years
maximum age: 79 Years
healthy volunteers: No
last name: Masood Jawaid, MRCS,FCPS
role: Study Director
affiliation: PharmEvo Pvt Ltd
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Common Cold
mesh term: Cough
sharing ipd: No