<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/NCT03787563</url>
  </required_header>
  <id_info>
    <org_study_id>CIMED - 001- 2018</org_study_id>
    <nct_id>NCT03787563</nct_id>
  </id_info>
  <brief_title>Herbal Tea in the Treatment of Type 2 Diabetes Mellitus</brief_title>
  <official_title>Herbal Tea for a Control of Blood Sugar in Subjects With Early Type 2 Diabetes: A Pilot Randomized Placebo Controlled Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Composite Interceptive Med Science</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Composite Interceptive Med-Science Laboratories Pvt Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Composite Interceptive Med Science</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>
      Diabetes mellitus is a chronic disease caused by inherited and/or acquired deficiency in&#xD;
      production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. It&#xD;
      has become a major healthcare problem in India. High-quality, low-cost solutions adapted to&#xD;
      the local context are critical to addressing the current crisis in the management of&#xD;
      diabetes. Herbal tea consists of tulsi, guava and stevia, which has glucose lowering&#xD;
      properties.The aim of this trial is to study the effect of a herbal tea in the glycemic&#xD;
      response in the early type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>all the subjects will receive sequence of different study treatments.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double blinded study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting Plasma Glucose (FPG)</measure>
    <time_frame>2 days and 5 days</time_frame>
    <description>Change from baseline in Fasting plasma glucose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Glucose Tolerance Test (OGTT)</measure>
    <time_frame>2 days and 5 days</time_frame>
    <description>Change from baseline in OGTT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subject with adverse events</measure>
    <time_frame>2 days and 5 days</time_frame>
    <description>Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Flash Glucose Measurements</measure>
    <time_frame>2 days and 5 days</time_frame>
    <description>Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Active Herbal tea</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One tea bag infusion three times a day each before breakfast, lunch and dinner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Tea</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Herbal Tea</intervention_name>
    <description>All participants will be given the intervention in an infusion tea bag. Participant will be instructed to take one tea bag three times a day at before breakfast, lunch and dinner meals. At the time of randomization both active and placebo infusion bag will be provided.There will be one day of washout period after 2 days on treatment.</description>
    <arm_group_label>Active Herbal tea</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Tea</intervention_name>
    <description>Similar looking inert placebo tea.</description>
    <arm_group_label>Placebo Tea</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults aged over 18 years and having a diagnosis of diabetes and meeting one of the&#xD;
        following criteria&#xD;
&#xD;
          1. Fasting Plasma Glucose ≥126 mg/dL, fasting defined as no caloric intake for at least 8&#xD;
             hours, AND&#xD;
&#xD;
          2. 2-h Post load Glucose ≥140 mg/dL during an OGTT. AND&#xD;
&#xD;
          3. Glycosylated haemoglobin (A1C) ≥ 6.5 %.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any one of the following&#xD;
&#xD;
          1. Patients on Insulin therapy.&#xD;
&#xD;
          2. Patients on oral hypoglycemic agents other than metformin&#xD;
&#xD;
          3. Any history suggestive of micro vascular or macro vascular disease - coronary artery&#xD;
             disease, stroke, peripheral artery disease or diabetes related retinal changes.&#xD;
&#xD;
          4. Women in child bearing age unable to practice any form of contraception&#xD;
&#xD;
          5. Patients with diagnosis of Anaemia (Hemoglobin &lt;11 g/dl in Female and &lt;13 g/dl in&#xD;
             Male)&#xD;
&#xD;
          6. Impaired renal function; estimated glomerular function &lt;60mls/min/1.73m2.&#xD;
&#xD;
          7. Known history of any chronic illness taking regular pharmacological agents.&#xD;
&#xD;
          8. Blood pressure fluctuations exceeding 20 mmHg on 2 subsequent clinic visits or known&#xD;
             history of hypotension or bradycardia in last 6 months or taking 3 or more&#xD;
             antihypertensive medications regularly in the last 6 weeks&#xD;
&#xD;
          9. Known history of autonomic dysfunction like diabetic autonomic neural imbalance or&#xD;
             neuropathy&#xD;
&#xD;
         10. Participating in another clinical trial with an active intervention or drug or device&#xD;
             with last dose taken within 60 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HD Ramachandra Prabhu, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Health India Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sanjaya Chauhan, Pharm.D</last_name>
    <phone>09611252350</phone>
    <email>drsanjayachauhan49@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Health India Hospital</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560029</zip>
        <country>India</country>
      </address>
    </facility>
    <contact>
      <last_name>Thirumalesha RL, BAMS</last_name>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 23, 2018</last_update_submitted>
  <last_update_submitted_qc>December 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Herbal Tea</keyword>
  <keyword>Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03787563
org study id: CIMED - 001- 2018
nct id: NCT03787563
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Diabetes mellitus is a chronic disease caused by inherited and/or acquired deficiency in
      production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. It
      has become a major healthcare problem in India. High-quality, low-cost solutions adapted to
      the local context are critical to addressing the current crisis in the management of
      diabetes. Herbal tea consists of tulsi, guava and stevia, which has glucose lowering
      properties.The aim of this trial is to study the effect of a herbal tea in the glycemic
      response in the early type 2 diabetes.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: all the subjects will receive sequence of different study treatments.
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double blinded study
measure: Fasting Plasma Glucose (FPG)
time frame: 2 days and 5 days
description: Change from baseline in Fasting plasma glucose
measure: Oral Glucose Tolerance Test (OGTT)
time frame: 2 days and 5 days
description: Change from baseline in OGTT
measure: Number of Subject with adverse events
time frame: 2 days and 5 days
description: Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment.
measure: Flash Glucose Measurements
time frame: 2 days and 5 days
description: Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor
arm group label: Active Herbal tea
arm group type: Active Comparator
description: One tea bag infusion three times a day each before breakfast, lunch and dinner.
arm group label: Placebo Tea
arm group type: Placebo Comparator
description: Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.
intervention type: Drug
intervention name: Herbal Tea
description: All participants will be given the intervention in an infusion tea bag. Participant will be instructed to take one tea bag three times a day at before breakfast, lunch and dinner meals. At the time of randomization both active and placebo infusion bag will be provided.There will be one day of washout period after 2 days on treatment.
arm group label: Active Herbal tea
intervention type: Drug
intervention name: Placebo Tea
description: Similar looking inert placebo tea.
arm group label: Placebo Tea
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: HD Ramachandra Prabhu, MBBS, MD
role: Principal Investigator
affiliation: Health India Hospital
last name: Sanjaya Chauhan, Pharm.D
phone: 09611252350
email: drsanjayachauhan49@gmail.com
facility: 
contact: 
country: India
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided