<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/NCT04426435</url>
  </required_header>
  <id_info>
    <org_study_id>22145</org_study_id>
    <nct_id>NCT04426435</nct_id>
  </id_info>
  <brief_title>Effects a Honey Based Syrup on Blood Parameters in Patients With Breast Cancer</brief_title>
  <official_title>Honey Based Syrup on Blood Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shiraz University of Medical Sciences</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>
      Study aim Determination of the effect of a honey based (HB) syrup on the blood parameters of&#xD;
      patients with breast cancer Design Two arm parallel group randomised clinical trial, double&#xD;
      blinded Settings and conduct Design of the study: Women patients with breast cancer referring&#xD;
      to Shohaday-e- Tajrish Hospital of Tehran who are under chemotherapy treatment. In order to&#xD;
      blind the investigator, medications are named as &quot;A&quot; for syrup of HB and B for placebo. The&#xD;
      patients don't aware of the type of drug they are assigned to. In addition, the groups are&#xD;
      entered into statistical analysis as &quot;A&quot; and &quot;B.&#xD;
&#xD;
      The patients will revive either A or B syrup for 4 weeks. At the beginning of the trial&#xD;
      demographic data would be gathered. Also, a blood sample would be drawn at the beginning time&#xD;
      and after the end of intervention period (week 4).&#xD;
&#xD;
      Data would be analysed by SPSS software using T-test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women patients with breast cancer referring to Shohaday-e- Tajrish Hospital of Tehran who are&#xD;
      under chemotherapy treatment. In order to blind the investigator, medications are named as&#xD;
      &quot;A&quot; for syrup of HB and B for placebo. The patients don't aware of the type of drug they are&#xD;
      assigned to. In addition, the groups are entered into statistical analysis as &quot;A&quot; and &quot;B.&#xD;
&#xD;
      The patients will revive either A or B syrup for 4 weeks. At the beginning of the trial&#xD;
      demographic data would be gathered. Also, a blood sample would be drawn at the beginning time&#xD;
      and after the end of intervention period (week 4).&#xD;
&#xD;
      Data would be analysed by SPSS software using T-test. Main outcome variables The mean of&#xD;
      score of &quot;Hemoglobine (Hb)&quot;, 2. The mean of score of &quot;white blood cell count (WBC)&quot;, 3. The&#xD;
      mean of score of &quot;platelet count (Plt)&quot;&#xD;
&#xD;
      Main outcome variables The mean of score of &quot;Hemoglobine (Hb)&quot;, 2. The mean of score of&#xD;
      &quot;white blood cell count (WBC)&quot;, 3. The mean of score of &quot;platelet count (Plt)&quot;&#xD;
&#xD;
      Participants/Inclusion and exclusion criteria Inclusion criteria: women suffer from breast&#xD;
      cancer who are; 1.Age between 18- 70 years old; 2. Hemoglobin level is at least 8g/dl; 3.&#xD;
      Hematocrit level at least 30%; 4. normal TSH. Exclusion criteria: 1. Heart disease with&#xD;
      unstable conditions; 2. Disabling Pulmonary Disease and History of Asthma; 3. Severe kidney&#xD;
      disease; 4. Creatinine level greater than 2mg/dl; 5. Proteinuria; 6. The SGOT level more than&#xD;
      3 times of the normal threshold; 7. Bilirubin levels greater than 2mg/dl; 8. Positive history&#xD;
      of hypersensitivity to saffron, rose water and honey; 9. severe infection; 10. Systemic&#xD;
      disease;11. Positive history of gout or high level of uric acid; 12. An individual who uses&#xD;
      antidepressants due to depression; 13. Simultaneous use of drugs that affect fatigue; 14.&#xD;
      Uncontrolled pain; 15. Unwillingness to participate in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">October 5, 2020</completion_date>
  <primary_completion_date type="Actual">September 25, 2020</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of mean score of Hemoglobin level of patients in intervention and placebo groups</measure>
    <time_frame>The weeks of 0 and 4 after treatment</time_frame>
    <description>A mean score of hemoglobin level is generally defined as 12.5 to 14.5 grams per deciliter (125-145 grams per liter) for women. Higher or lower scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of mean score of WBC count of patients in intervention and placebo groups</measure>
    <time_frame>The weeks of 0 and 4 after treatment</time_frame>
    <description>A mean score of WBC count is usually between 4,000 and 11,000 per microliter of blood for women. Higher or lower scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of mean score of Plt count of patients in intervention and placebo groups</measure>
    <time_frame>The weeks of 0 and 4 after treatment</time_frame>
    <description>A mean score of Plt count is usually ranges from 150,000 to 450,000 platelets per microliter of blood for women. Higher or lower scores mean a worse outcome.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A: patients receiving HB syrup, 10 cc three times daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group B: patients receiving placebo, 10 cc three times daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>honey based (HB) syrup</intervention_name>
    <description>honey-based syrup is prepared according to the documented Persian Medicine manuscripts with some modifications. HB is a mixture of honey, rose water and saffron. Each 100g of HB consisted of 79.87 g honey, 19.97 g rose water, and 0.16 g saffron.&#xD;
All the ingredients were licensed and approved by The Islamic Republic of Iran Food and Drug Organization (I.R.I.FDO).</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female gender&#xD;
&#xD;
          -  Age between 18- 70 years old Patients&#xD;
&#xD;
          -  known case of breast cancer&#xD;
&#xD;
          -  Hemoglobin level is at least 8 g / dl&#xD;
&#xD;
          -  Hematocrit level at least 30% The level of&#xD;
&#xD;
          -  TSH is normal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients known case of heart disease with unstable conditions&#xD;
&#xD;
          -  Disabling Pulmonary Disease and History of Asthma&#xD;
&#xD;
          -  Patients known case of severe kidney disease (Creatinine level is greater than 2mg /&#xD;
             dl Proteinuria)&#xD;
&#xD;
          -  The SGOT level is more than 3 times of the normal threshold&#xD;
&#xD;
          -  Bilirubin levels is greater than 2mg / dl&#xD;
&#xD;
          -  Positive history of hypersensitivity to saffron, Rose water and Honey&#xD;
&#xD;
          -  Uncontrolled pain&#xD;
&#xD;
          -  severe infection&#xD;
&#xD;
          -  serious illness&#xD;
&#xD;
          -  Positive history of gout or high level of uric acid&#xD;
&#xD;
          -  An individual who uses antidepressants due to depression&#xD;
&#xD;
          -  Simultaneous use of drugs that affect blood cells&#xD;
&#xD;
          -  Unwillingness to participate in the study&#xD;
&#xD;
          -  Active treatment for anemia (transfusion or Epoetin Alfa Injection)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehdi Pasalar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shohaday-e- Tajrish Hospital</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Pasalar M, Choopani R, Mosaddegh M, Kamalinejad M, Mohagheghzadeh A, Fattahi MR, Ghanizadeh A, Bagheri Lankarani K. Efficacy and safety of jollab to treat functional dyspepsia: a randomized placebo-controlled clinical trial. Explore (NY). 2015 May-Jun;11(3):199-207. doi: 10.1016/j.explore.2015.02.007. Epub 2015 Feb 17.</citation>
    <PMID>25777290</PMID>
  </results_reference>
  <results_reference>
    <citation>Pasalar M, Choopani R, Mosaddegh M, Kamalinejad M, Mohagheghzadeh A, Fattahi MR, Zarshenas MM, Jafari P, Lankarani KB. Efficacy of jollab in the treatment of depression in dyspeptic patients: a randomized double-blind controlled trial. J Evid Based Complementary Altern Med. 2015 Apr;20(2):104-8. doi: 10.1177/2156587214563542. Epub 2015 Jan 13.</citation>
    <PMID>25587004</PMID>
  </results_reference>
  <results_reference>
    <citation>Emtiazy M, Oveidzadeh L, Habibi M, Molaeipour L, Talei D, Jafari Z, Parvin M, Kamalinejad M. Investigating the effectiveness of the Trigonella foenum-graecum L. (fenugreek) seeds in mild asthma: a randomized controlled trial. Allergy Asthma Clin Immunol. 2018 May 2;14:19. doi: 10.1186/s13223-018-0238-9. eCollection 2018.</citation>
    <PMID>29743896</PMID>
  </results_reference>
  <results_reference>
    <citation>Taavoni S, Fathi L, Nazem-Ekbatani N, Haghani H. The Effect of Oral Intake of Honey Syrup on the Pain Intensity of Active Phase of Parturition of nulliparous women: A Randomized clinical trial. Caspian J Intern Med. 2019 Winter;10(1):98-101. doi: 10.22088/cjim.10.1.98.</citation>
    <PMID>30858948</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mehdi Pasalar</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>honey</keyword>
  <keyword>blood</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT04426435
org study id: 22145
nct id: NCT04426435
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study aim Determination of the effect of a honey based (HB) syrup on the blood parameters of
      patients with breast cancer Design Two arm parallel group randomised clinical trial, double
      blinded Settings and conduct Design of the study: Women patients with breast cancer referring
      to Shohaday-e- Tajrish Hospital of Tehran who are under chemotherapy treatment. In order to
      blind the investigator, medications are named as "A" for syrup of HB and B for placebo. The
      patients don't aware of the type of drug they are assigned to. In addition, the groups are
      entered into statistical analysis as "A" and "B.

      The patients will revive either A or B syrup for 4 weeks. At the beginning of the trial
      demographic data would be gathered. Also, a blood sample would be drawn at the beginning time
      and after the end of intervention period (week 4).

      Data would be analysed by SPSS software using T-test.
Women patients with breast cancer referring to Shohaday-e- Tajrish Hospital of Tehran who are
      under chemotherapy treatment. In order to blind the investigator, medications are named as
      "A" for syrup of HB and B for placebo. The patients don't aware of the type of drug they are
      assigned to. In addition, the groups are entered into statistical analysis as "A" and "B.

      The patients will revive either A or B syrup for 4 weeks. At the beginning of the trial
      demographic data would be gathered. Also, a blood sample would be drawn at the beginning time
      and after the end of intervention period (week 4).

      Data would be analysed by SPSS software using T-test. Main outcome variables The mean of
      score of "Hemoglobine (Hb)", 2. The mean of score of "white blood cell count (WBC)", 3. The
      mean of score of "platelet count (Plt)"

      Main outcome variables The mean of score of "Hemoglobine (Hb)", 2. The mean of score of
      "white blood cell count (WBC)", 3. The mean of score of "platelet count (Plt)"

      Participants/Inclusion and exclusion criteria Inclusion criteria: women suffer from breast
      cancer who are; 1.Age between 18- 70 years old; 2. Hemoglobin level is at least 8g/dl; 3.
      Hematocrit level at least 30%; 4. normal TSH. Exclusion criteria: 1. Heart disease with
      unstable conditions; 2. Disabling Pulmonary Disease and History of Asthma; 3. Severe kidney
      disease; 4. Creatinine level greater than 2mg/dl; 5. Proteinuria; 6. The SGOT level more than
      3 times of the normal threshold; 7. Bilirubin levels greater than 2mg/dl; 8. Positive history
      of hypersensitivity to saffron, rose water and honey; 9. severe infection; 10. Systemic
      disease;11. Positive history of gout or high level of uric acid; 12. An individual who uses
      antidepressants due to depression; 13. Simultaneous use of drugs that affect fatigue; 14.
      Uncontrolled pain; 15. Unwillingness to participate in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The change of mean score of Hemoglobin level of patients in intervention and placebo groups
time frame: The weeks of 0 and 4 after treatment
description: A mean score of hemoglobin level is generally defined as 12.5 to 14.5 grams per deciliter (125-145 grams per liter) for women. Higher or lower scores mean a worse outcome.
measure: The change of mean score of WBC count of patients in intervention and placebo groups
time frame: The weeks of 0 and 4 after treatment
description: A mean score of WBC count is usually between 4,000 and 11,000 per microliter of blood for women. Higher or lower scores mean a worse outcome.
measure: The change of mean score of Plt count of patients in intervention and placebo groups
time frame: The weeks of 0 and 4 after treatment
description: A mean score of Plt count is usually ranges from 150,000 to 450,000 platelets per microliter of blood for women. Higher or lower scores mean a worse outcome.
arm group label: Intervention
arm group type: Experimental
description: Group A: patients receiving HB syrup, 10 cc three times daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Group B: patients receiving placebo, 10 cc three times daily
intervention type: Drug
intervention name: honey based (HB) syrup
description: honey-based syrup is prepared according to the documented Persian Medicine manuscripts with some modifications. HB is a mixture of honey, rose water and saffron. Each 100g of HB consisted of 79.87 g honey, 19.97 g rose water, and 0.16 g saffron.
All the ingredients were licensed and approved by The Islamic Republic of Iran Food and Drug Organization (I.R.I.FDO).
arm group label: Intervention
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mehdi Pasalar
role: Principal Investigator
affiliation: Shiraz University of Medical Sciences
facility: 
country: Iran, Islamic Republic of
citation: Pasalar M, Choopani R, Mosaddegh M, Kamalinejad M, Mohagheghzadeh A, Fattahi MR, Ghanizadeh A, Bagheri Lankarani K. Efficacy and safety of jollab to treat functional dyspepsia: a randomized placebo-controlled clinical trial. Explore (NY). 2015 May-Jun;11(3):199-207. doi: 10.1016/j.explore.2015.02.007. Epub 2015 Feb 17.
PMID: 25777290
citation: Pasalar M, Choopani R, Mosaddegh M, Kamalinejad M, Mohagheghzadeh A, Fattahi MR, Zarshenas MM, Jafari P, Lankarani KB. Efficacy of jollab in the treatment of depression in dyspeptic patients: a randomized double-blind controlled trial. J Evid Based Complementary Altern Med. 2015 Apr;20(2):104-8. doi: 10.1177/2156587214563542. Epub 2015 Jan 13.
PMID: 25587004
citation: Emtiazy M, Oveidzadeh L, Habibi M, Molaeipour L, Talei D, Jafari Z, Parvin M, Kamalinejad M. Investigating the effectiveness of the Trigonella foenum-graecum L. (fenugreek) seeds in mild asthma: a randomized controlled trial. Allergy Asthma Clin Immunol. 2018 May 2;14:19. doi: 10.1186/s13223-018-0238-9. eCollection 2018.
PMID: 29743896
citation: Taavoni S, Fathi L, Nazem-Ekbatani N, Haghani H. The Effect of Oral Intake of Honey Syrup on the Pain Intensity of Active Phase of Parturition of nulliparous women: A Randomized clinical trial. Caspian J Intern Med. 2019 Winter;10(1):98-101. doi: 10.22088/cjim.10.1.98.
PMID: 30858948
responsible party type: Principal Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: Mehdi Pasalar
investigator title: assistant professor
mesh term: Breast Neoplasms
sharing ipd: No