<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/NCT04443790</url>
  </required_header>
  <id_info>
    <org_study_id>GCUF/ERC/1817</org_study_id>
    <nct_id>NCT04443790</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Polyherbal Coded Formulation Obesecure for Leptin Regulation and Obesity Management</brief_title>
  <acronym>CEOLO</acronym>
  <official_title>Obesity Control Through Leptogenic Drugs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hafiz Muhammad Asif</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hamdard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Government College University Faisalabad</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shifa Ul Mulk Memorial Hospital</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 study was designed to explore an alternative approach to reduce weight in human beings&#xD;
      using a polyherbal formulation. A polyherbal formulation named as Obesecure was developed&#xD;
      after screening of local medicinal flora. The formulation was further improved after pilot&#xD;
      studies and Phase-I Clinical Trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is a common disease of developing countries including Pakistan. Obesity is a risk&#xD;
      factor for many diseases which can be life-threatening or making the person unable to perform&#xD;
      daily routine work. Obesity is considered a risk factor for different diseases like&#xD;
      cardiovascular diseases, hormonal imbalance, infections, malignancies and chest problems. The&#xD;
      leptin hormone has appetite suppressing and energy dissipation activity in the body. A&#xD;
      screening study on animals was carried out to find out the leptin enhancing medicinal plants&#xD;
      from locally available plants in Pakistan. This study was aimed to see the combined effects&#xD;
      of the Leptogenic drug Obesecure on weight management.&#xD;
&#xD;
      Patients of age20 to 50 years with BMI more than 25, not taking any anti-obesity drugs&#xD;
      one-month prior to start of study were enrolled. The Participants were randomly allocated to&#xD;
      receive either Obesecure or placebo twice a day for three months in Shifa-ul-mulk Hospital,&#xD;
      PRIEM Health Care Clinic (Pakistan) and Ria Eastern Medicine Clinic (Pakistan).&#xD;
&#xD;
      An acute toxicity study showed no adverse effect of taking Obesecure prior to clinical&#xD;
      trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2015</start_date>
  <completion_date type="Actual">May 20, 2018</completion_date>
  <primary_completion_date type="Actual">March 20, 2018</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>
    <intervention_model_description>Multicentre, two arm parallel randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Leptin Level</measure>
    <time_frame>3 months</time_frame>
    <description>Appetite suppression and energy dissipation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI (kg/m²) at baseline</measure>
    <time_frame>3 Months</time_frame>
    <description>weight reduction effects</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Leptin Deficiency</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Obesecure Capsules (Test Group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A dose of 500mg capsule twice daily of Polyherbal formulation Obesecure was given in the test group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plasicure (Control Group)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A dose of 500mg capsule twice daily of Placebo as Plasicure was given in the control group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leptin Human</intervention_name>
    <arm_group_label>Obesecure Capsules (Test Group)</arm_group_label>
    <arm_group_label>Plasicure (Control Group)</arm_group_label>
    <other_name>Obesecure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of age20 to 50 years with BMI more than 25&#xD;
&#xD;
          2. Only those participants were included who were willing&#xD;
&#xD;
          3. Patients of any marital status were included&#xD;
&#xD;
          4. Only those participants were included who did not take any antiobesity drug one-month&#xD;
             prior to start of study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Taking an anti-obesity drug in the previous month&#xD;
&#xD;
          2. Pregnant&#xD;
&#xD;
          3. Allergic to laxative drugs&#xD;
&#xD;
          4. Recurrent weight gain history after antiobesity treatment&#xD;
&#xD;
          5. Liver disease&#xD;
&#xD;
          6. Taking hormonal therapy, menopausal women&#xD;
&#xD;
          7. Diabetes mellitus&#xD;
&#xD;
          8. Cardiac problem and hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ejaz Mohiuddin, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Hamdard University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>clinical trial was conducted in Karachi,Islamabad and Faisalabad</name>
      <address>
        <city>Karachi</city>
        <state>Punjab</state>
        <zip>74600</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Wasim M, Awan FR, Najam SS, Khan AR, Khan HN. Role of Leptin Deficiency, Inefficiency, and Leptin Receptors in Obesity. Biochem Genet. 2016 Oct;54(5):565-72. doi: 10.1007/s10528-016-9751-z. Epub 2016 Jun 16.</citation>
    <PMID>27313173</PMID>
  </reference>
  <reference>
    <citation>Farr OM, Gavrieli A, Mantzoros CS. Leptin applications in 2015: what have we learned about leptin and obesity? Curr Opin Endocrinol Diabetes Obes. 2015 Oct;22(5):353-9. doi: 10.1097/MED.0000000000000184.</citation>
    <PMID>26313897</PMID>
  </reference>
  <results_reference>
    <citation>Lee JH, Lee JJ, Cho WK, Yim NH, Kim HK, Yun B, Ma JY. KBH-1, an herbal composition, improves hepatic steatosis and leptin resistance in high-fat diet-induced obese rats. BMC Complement Altern Med. 2016 Sep 13;16(1):355. doi: 10.1186/s12906-016-1265-z.</citation>
    <PMID>27618865</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shifa Ul Mulk Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Hafiz Muhammad Asif</investigator_full_name>
    <investigator_title>Clinical Trials Registrar for Shifaulmulk</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will be shared to other researchers on request</ipd_description>
  </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/NCT04443790
org study id: GCUF/ERC/1817
nct id: NCT04443790
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study was designed to explore an alternative approach to reduce weight in human beings
      using a polyherbal formulation. A polyherbal formulation named as Obesecure was developed
      after screening of local medicinal flora. The formulation was further improved after pilot
      studies and Phase-I Clinical Trials.
Obesity is a common disease of developing countries including Pakistan. Obesity is a risk
      factor for many diseases which can be life-threatening or making the person unable to perform
      daily routine work. Obesity is considered a risk factor for different diseases like
      cardiovascular diseases, hormonal imbalance, infections, malignancies and chest problems. The
      leptin hormone has appetite suppressing and energy dissipation activity in the body. A
      screening study on animals was carried out to find out the leptin enhancing medicinal plants
      from locally available plants in Pakistan. This study was aimed to see the combined effects
      of the Leptogenic drug Obesecure on weight management.

      Patients of age20 to 50 years with BMI more than 25, not taking any anti-obesity drugs
      one-month prior to start of study were enrolled. The Participants were randomly allocated to
      receive either Obesecure or placebo twice a day for three months in Shifa-ul-mulk Hospital,
      PRIEM Health Care Clinic (Pakistan) and Ria Eastern Medicine Clinic (Pakistan).

      An acute toxicity study showed no adverse effect of taking Obesecure prior to clinical
      trials.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multicentre, two arm parallel randomized controlled clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Leptin Level
time frame: 3 months
description: Appetite suppression and energy dissipation
measure: BMI (kg/m²) at baseline
time frame: 3 Months
description: weight reduction effects
arm group label: Obesecure Capsules (Test Group)
arm group type: Active Comparator
description: A dose of 500mg capsule twice daily of Polyherbal formulation Obesecure was given in the test group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months.
arm group label: Plasicure (Control Group)
arm group type: Placebo Comparator
description: A dose of 500mg capsule twice daily of Placebo as Plasicure was given in the control group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months.
intervention type: Drug
intervention name: Leptin Human
arm group label: Obesecure Capsules (Test Group)
arm group label: Plasicure (Control Group)
other name: Obesecure
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ejaz Mohiuddin, Ph.D
role: Study Director
affiliation: Hamdard University
facility: 
country: Pakistan
citation: Wasim M, Awan FR, Najam SS, Khan AR, Khan HN. Role of Leptin Deficiency, Inefficiency, and Leptin Receptors in Obesity. Biochem Genet. 2016 Oct;54(5):565-72. doi: 10.1007/s10528-016-9751-z. Epub 2016 Jun 16.
PMID: 27313173
citation: Farr OM, Gavrieli A, Mantzoros CS. Leptin applications in 2015: what have we learned about leptin and obesity? Curr Opin Endocrinol Diabetes Obes. 2015 Oct;22(5):353-9. doi: 10.1097/MED.0000000000000184.
PMID: 26313897
citation: Lee JH, Lee JJ, Cho WK, Yim NH, Kim HK, Yun B, Ma JY. KBH-1, an herbal composition, improves hepatic steatosis and leptin resistance in high-fat diet-induced obese rats. BMC Complement Altern Med. 2016 Sep 13;16(1):355. doi: 10.1186/s12906-016-1265-z.
PMID: 27618865
responsible party type: Sponsor-Investigator
investigator affiliation: Shifa Ul Mulk Memorial Hospital
investigator full name: Hafiz Muhammad Asif
investigator title: Clinical Trials Registrar for Shifaulmulk
mesh term: Obesity
mesh term: Obesity, Morbid
sharing ipd: No
ipd description: IPD will be shared to other researchers on request