<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/NCT04482907</url>
  </required_header>
  <id_info>
    <org_study_id>12.2014/21</org_study_id>
    <nct_id>NCT04482907</nct_id>
  </id_info>
  <brief_title>Effect of Dill in Thyroiditis and Nodular Goiter Patients</brief_title>
  <acronym>Dill</acronym>
  <official_title>Randomized Placebo Controlled Clinical Study of Anethum Graveolens L. (Dill) in Thyroiditis and Nodular Goiter Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</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 aim of the study was to investigate the functional and morphological effects of Anethum&#xD;
      graveolens L. in patients with thyroiditis and nodular goiter by evaluating hormone levels,&#xD;
      anti-Inflammatory markers and comparing thyroid nodule sizes measured by ultrasonography for&#xD;
      90 days.&#xD;
&#xD;
      The effect of Anethum graveolens L. was evaluated in euthyroid goiter patients diagnosed with&#xD;
      benign thyroid nodule via fine needle aspiration biopsy. Aerial parts of Anethum graveolens&#xD;
      L. were dried and grinded to yield a fine powder. Size 1 hydroxypropyl methylcellulose&#xD;
      capsules were filled with 300 mg powder. Placebo was prepared in the same manner using&#xD;
      maltodextrin. Patients were suggested to take 3 pills a day. Blood samples were collected at&#xD;
      the initial and the final day for thyroid stimulating hormone (TSH), free triiodothyronine&#xD;
      (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg)&#xD;
      and C-reactive protein (CRP) analysis. Nodule sizes were also measured at the beginning and&#xD;
      at the end of the trial with ultrasonography to identify the changes and effectiveness of&#xD;
      dill dosage forms.&#xD;
&#xD;
      After 90 days in the study, the status of TSH, fT3, fT4, anti-TPO and CRP levels were&#xD;
      examined in the group with and without Anethum graveolens L..&#xD;
&#xD;
      Again, after the study, the size of thyroid nodules was evaluated in the group who received&#xD;
      and did not receive Anethum graveolens L. by ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">April 5, 2020</completion_date>
  <primary_completion_date type="Actual">December 16, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Two groups were created. Patients with thyroid nodules were divided into two groups given dill and placebo. The study was planned for 90 days. 900 mg of powder dill was given daily to the dill group. Placebo was given to the control group. Serum thyroid stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg) and C-reactive protein (CRP) levels of both groups were examined at the beginning and at the end of the study. Thyroid nodule dimensions were measured at the beginning and at the end of the study by ultrasonography. The results were evaluated statistically.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of thyroid stimulating hormone (TSH) between groups</measure>
    <time_frame>90 days</time_frame>
    <description>At the beginning and at the end of the study, the levels of serum TSH were measured and statistically compared in groups given Anethum graveolens L. and placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of free triiodothyronine (fT3) between groups</measure>
    <time_frame>90 days</time_frame>
    <description>At the beginning and at the end of the study, the levels of serum fT3 were measured and statistically compared in groups given Anethum graveolens L. and placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of free thyroxine (fT4) between groups</measure>
    <time_frame>90 days</time_frame>
    <description>At the beginning and at the end of the study, the levels of serum fT4 were measured and statistically compared in groups given Anethum graveolens L. and placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of anti-thyroid peroxidase (anti-TPO) between groups</measure>
    <time_frame>90 days</time_frame>
    <description>At the beginning and at the end of the study, the levels of anti-TPO were measured and statistically compared in groups given Anethum graveolens L. and placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of anti-thyroglobulin (Anti-Tg) between groups</measure>
    <time_frame>90 days</time_frame>
    <description>At the beginning and at the end of the study, the levels of serum Anti-Tg were measured and statistically compared in groups given Anethum graveolens L. and placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of C-reactive protein (CRP) between groups</measure>
    <time_frame>90 days</time_frame>
    <description>At the beginning and at the end of the study, the levels of serum CRP were measured and statistically compared in groups given Anethum graveolens L. and placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of ultrasound and thyroid nodule sizes between groups</measure>
    <time_frame>90 days</time_frame>
    <description>At the beginning and end of the study, thyroid nodule sizes (mm) were measured and statistically compared in groups given Anethum graveolens L. and placebo.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Thyroid Nodule</condition>
  <arm_group>
    <arm_group_label>Group receiving dill</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>They took 3 meals a day, 3x300 mg dry dill powder by mouth. They bought dry dill powder for 90 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group receiving placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>They took 3 meals a day and 3 cellulose placebo capsules by mouth. They took placebo capsules for 90 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.</intervention_name>
    <description>Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP</description>
    <arm_group_label>Group receiving dill</arm_group_label>
    <arm_group_label>Group receiving placebo</arm_group_label>
    <other_name>Taking blood from the arm intravenously at the beginning and end of the study and looking for thyroid hormones from this blood.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To have multi-nodular goiter,&#xD;
&#xD;
          -  To be a benign result in fine needle aspiration biopsy,&#xD;
&#xD;
          -  Euthyroid must be sick,&#xD;
&#xD;
          -  Must be sick over the age of 18,&#xD;
&#xD;
          -  To accept the research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Thyroid function tests non-euthyroid individuals,&#xD;
&#xD;
          -  To have a malignant result in thyroid biopsy,&#xD;
&#xD;
          -  Not giving approval,&#xD;
&#xD;
          -  To be renal failure,&#xD;
&#xD;
          -  Benign pregnant,&#xD;
&#xD;
          -  Taking blood thinning drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayşegul Yabacı, research</last_name>
    <role>Study Chair</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sabahattin Destek</name>
      <address>
        <city>Fatih</city>
        <state>Istanbul</state>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Jana S, Shekhawat GS. Anethum graveolens: An Indian traditional medicinal herb and spice. Pharmacogn Rev. 2010 Jul;4(8):179-84. doi: 10.4103/0973-7847.70915.</citation>
    <PMID>22228959</PMID>
  </results_reference>
  <results_reference>
    <citation>Orhan IE, Senol FS, Ozturk N, Celik SA, Pulur A, Kan Y. Phytochemical contents and enzyme inhibitory and antioxidant properties of Anethum graveolens L. (dill) samples cultivated under organic and conventional agricultural conditions. Food Chem Toxicol. 2013 Sep;59:96-103. doi: 10.1016/j.fct.2013.05.053. Epub 2013 Jun 10.</citation>
    <PMID>23764360</PMID>
  </results_reference>
  <results_reference>
    <citation>Antonelli A, Ferrari SM, Corrado A, Di Domenicantonio A, Fallahi P. Autoimmune thyroid disorders. Autoimmun Rev. 2015 Feb;14(2):174-80. doi: 10.1016/j.autrev.2014.10.016. Epub 2014 Oct 25.</citation>
    <PMID>25461470</PMID>
  </results_reference>
  <results_reference>
    <citation>Kratky J, Vitkova H, Bartakova J, Telicka Z, Antosova M, Limanova Z, Jiskra J. Thyroid nodules: pathophysiological insight on oncogenesis and novel diagnostic techniques. Physiol Res. 2014;63 Suppl 2(Suppl 2):S263-75. doi: 10.33549/physiolres.932818.</citation>
    <PMID>24908232</PMID>
  </results_reference>
  <results_reference>
    <citation>Yang ML, Lu B. Treatment of Goiter with Traditional Chinese Medicine Regimen Xing Qi Hua Ying Tang: A Clinical Study on 72 Patients with Multinodular and Diffuse Goiter. J Altern Complement Med. 2018 Apr;24(4):374-377. doi: 10.1089/acm.2017.0138. Epub 2017 Dec 7.</citation>
    <PMID>29215302</PMID>
  </results_reference>
  <results_reference>
    <citation>Altay M, Ates I, Kaplan Efe F, Karadag I. Does Use of Anethum Graveolens Affected Thyroid Hormone Levels and Thyroid Nodules? Am J Ther. 2017 Sep/Oct;24(5):e627-e629. doi: 10.1097/MJT.0000000000000511. No abstract available.</citation>
    <PMID>27753646</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anethum graveolens L.</keyword>
  <keyword>Thyroiditis</keyword>
  <keyword>Nodular Goiter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Goiter</mesh_term>
    <mesh_term>Thyroiditis</mesh_term>
    <mesh_term>Goiter, Nodular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>When published as a full article in a journal indexed, IPD will be shared.</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/NCT04482907
org study id: 12.2014/21
nct id: NCT04482907
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to investigate the functional and morphological effects of Anethum
      graveolens L. in patients with thyroiditis and nodular goiter by evaluating hormone levels,
      anti-Inflammatory markers and comparing thyroid nodule sizes measured by ultrasonography for
      90 days.

      The effect of Anethum graveolens L. was evaluated in euthyroid goiter patients diagnosed with
      benign thyroid nodule via fine needle aspiration biopsy. Aerial parts of Anethum graveolens
      L. were dried and grinded to yield a fine powder. Size 1 hydroxypropyl methylcellulose
      capsules were filled with 300 mg powder. Placebo was prepared in the same manner using
      maltodextrin. Patients were suggested to take 3 pills a day. Blood samples were collected at
      the initial and the final day for thyroid stimulating hormone (TSH), free triiodothyronine
      (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg)
      and C-reactive protein (CRP) analysis. Nodule sizes were also measured at the beginning and
      at the end of the trial with ultrasonography to identify the changes and effectiveness of
      dill dosage forms.

      After 90 days in the study, the status of TSH, fT3, fT4, anti-TPO and CRP levels were
      examined in the group with and without Anethum graveolens L..

      Again, after the study, the size of thyroid nodules was evaluated in the group who received
      and did not receive Anethum graveolens L. by ultrasonography.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups were created. Patients with thyroid nodules were divided into two groups given dill and placebo. The study was planned for 90 days. 900 mg of powder dill was given daily to the dill group. Placebo was given to the control group. Serum thyroid stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (Anti-Tg) and C-reactive protein (CRP) levels of both groups were examined at the beginning and at the end of the study. Thyroid nodule dimensions were measured at the beginning and at the end of the study by ultrasonography. The results were evaluated statistically.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Comparison of thyroid stimulating hormone (TSH) between groups
time frame: 90 days
description: At the beginning and at the end of the study, the levels of serum TSH were measured and statistically compared in groups given Anethum graveolens L. and placebo.
measure: Comparison of free triiodothyronine (fT3) between groups
time frame: 90 days
description: At the beginning and at the end of the study, the levels of serum fT3 were measured and statistically compared in groups given Anethum graveolens L. and placebo.
measure: Comparison of free thyroxine (fT4) between groups
time frame: 90 days
description: At the beginning and at the end of the study, the levels of serum fT4 were measured and statistically compared in groups given Anethum graveolens L. and placebo.
measure: Comparison of anti-thyroid peroxidase (anti-TPO) between groups
time frame: 90 days
description: At the beginning and at the end of the study, the levels of anti-TPO were measured and statistically compared in groups given Anethum graveolens L. and placebo.
measure: Comparison of anti-thyroglobulin (Anti-Tg) between groups
time frame: 90 days
description: At the beginning and at the end of the study, the levels of serum Anti-Tg were measured and statistically compared in groups given Anethum graveolens L. and placebo.
measure: Comparison of C-reactive protein (CRP) between groups
time frame: 90 days
description: At the beginning and at the end of the study, the levels of serum CRP were measured and statistically compared in groups given Anethum graveolens L. and placebo.
measure: Comparison of ultrasound and thyroid nodule sizes between groups
time frame: 90 days
description: At the beginning and end of the study, thyroid nodule sizes (mm) were measured and statistically compared in groups given Anethum graveolens L. and placebo.
arm group label: Group receiving dill
arm group type: Active Comparator
description: They took 3 meals a day, 3x300 mg dry dill powder by mouth. They bought dry dill powder for 90 days.
arm group label: Group receiving placebo
arm group type: Placebo Comparator
description: They took 3 meals a day and 3 cellulose placebo capsules by mouth. They took placebo capsules for 90 days.
intervention type: Dietary Supplement
intervention name: Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.
description: Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP
arm group label: Group receiving dill
arm group label: Group receiving placebo
other name: Taking blood from the arm intravenously at the beginning and end of the study and looking for thyroid hormones from this blood.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 76 Years
healthy volunteers: No
last name: Ayşegul Yabacı, research
role: Study Chair
affiliation: Bezmialem Vakif University
facility: 
country: Turkey
citation: Jana S, Shekhawat GS. Anethum graveolens: An Indian traditional medicinal herb and spice. Pharmacogn Rev. 2010 Jul;4(8):179-84. doi: 10.4103/0973-7847.70915.
PMID: 22228959
citation: Orhan IE, Senol FS, Ozturk N, Celik SA, Pulur A, Kan Y. Phytochemical contents and enzyme inhibitory and antioxidant properties of Anethum graveolens L. (dill) samples cultivated under organic and conventional agricultural conditions. Food Chem Toxicol. 2013 Sep;59:96-103. doi: 10.1016/j.fct.2013.05.053. Epub 2013 Jun 10.
PMID: 23764360
citation: Antonelli A, Ferrari SM, Corrado A, Di Domenicantonio A, Fallahi P. Autoimmune thyroid disorders. Autoimmun Rev. 2015 Feb;14(2):174-80. doi: 10.1016/j.autrev.2014.10.016. Epub 2014 Oct 25.
PMID: 25461470
citation: Kratky J, Vitkova H, Bartakova J, Telicka Z, Antosova M, Limanova Z, Jiskra J. Thyroid nodules: pathophysiological insight on oncogenesis and novel diagnostic techniques. Physiol Res. 2014;63 Suppl 2(Suppl 2):S263-75. doi: 10.33549/physiolres.932818.
PMID: 24908232
citation: Yang ML, Lu B. Treatment of Goiter with Traditional Chinese Medicine Regimen Xing Qi Hua Ying Tang: A Clinical Study on 72 Patients with Multinodular and Diffuse Goiter. J Altern Complement Med. 2018 Apr;24(4):374-377. doi: 10.1089/acm.2017.0138. Epub 2017 Dec 7.
PMID: 29215302
citation: Altay M, Ates I, Kaplan Efe F, Karadag I. Does Use of Anethum Graveolens Affected Thyroid Hormone Levels and Thyroid Nodules? Am J Ther. 2017 Sep/Oct;24(5):e627-e629. doi: 10.1097/MJT.0000000000000511. No abstract available.
PMID: 27753646
responsible party type: Sponsor
mesh term: Thyroid Nodule
mesh term: Goiter
mesh term: Thyroiditis
mesh term: Goiter, Nodular
mesh term: Hormones
sharing ipd: No
ipd description: When published as a full article in a journal indexed, IPD will be shared.