Effect of Dill in Thyroiditis and Nodular Goiter Patients (Dill)

July 20, 2020 updated by: Bezmialem Vakif University

Randomized Placebo Controlled Clinical Study of Anethum Graveolens L. (Dill) in Thyroiditis and Nodular Goiter Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Istanbul
      • Fatih, Istanbul, Turkey, 34093
        • Sabahattin Destek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To have multi-nodular goiter,
  • To be a benign result in fine needle aspiration biopsy,
  • Euthyroid must be sick,
  • Must be sick over the age of 18,
  • To accept the research.

Exclusion Criteria:

  • Thyroid function tests non-euthyroid individuals,
  • To have a malignant result in thyroid biopsy,
  • Not giving approval,
  • To be renal failure,
  • Benign pregnant,
  • Taking blood thinning drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group receiving dill
They took 3 meals a day, 3x300 mg dry dill powder by mouth. They bought dry dill powder for 90 days.
Dietary supplement: Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.
Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP
Other Names:
  • Taking blood from the arm intravenously at the beginning and end of the study and looking for thyroid hormones from this blood.
Placebo Comparator: Group receiving placebo
They took 3 meals a day and 3 cellulose placebo capsules by mouth. They took placebo capsules for 90 days.
Dietary supplement: Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.
Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP
Other Names:
  • Taking blood from the arm intravenously at the beginning and end of the study and looking for thyroid hormones from this blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of thyroid stimulating hormone (TSH) between groups
Time Frame: 90 days
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.
90 days
Comparison of free triiodothyronine (fT3) between groups
Time Frame: 90 days
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.
90 days
Comparison of free thyroxine (fT4) between groups
Time Frame: 90 days
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.
90 days
Comparison of anti-thyroid peroxidase (anti-TPO) between groups
Time Frame: 90 days
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.
90 days
Comparison of anti-thyroglobulin (Anti-Tg) between groups
Time Frame: 90 days
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.
90 days
Comparison of C-reactive protein (CRP) between groups
Time Frame: 90 days
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.
90 days
Comparison of ultrasound and thyroid nodule sizes between groups
Time Frame: 90 days
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Chair: Ayşegul Yabacı, research, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

December 16, 2019

Study Completion (Actual)

April 5, 2020

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.2014/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

When published as a full article in a journal indexed, IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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