NCT04482907

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

July 16, 2020

Last Update Submit

July 20, 2020

Conditions

Thyroid Nodule

Keywords

Anethum graveolens L.ThyroiditisNodular Goiter

Outcome Measures

Primary Outcomes (7)

  • Comparison of thyroid stimulating hormone (TSH) between groups

    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

    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

    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

    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

    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

    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

    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

Study Arms (2)

Group receiving dill

ACTIVE COMPARATOR

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.

Group receiving placebo

PLACEBO COMPARATOR

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.

Interventions

Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.DIETARY_SUPPLEMENT

Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP

Also known as: Taking blood from the arm intravenously at the beginning and end of the study and looking for thyroid hormones from this blood.
Group receiving dillGroup receiving placebo

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sabahattin Destek

Fatih, Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (6)

  • 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: 22228959RESULT

  • 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: 23764360RESULT

  • 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: 25461470RESULT

  • 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: 24908232RESULT

  • 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: 29215302RESULT

  • 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: 27753646RESULT

MeSH Terms

Conditions

Thyroid NoduleThyroiditisGoiter, Nodular

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesGoiter

Study Officials

  • Ayşegul Yabacı, research

    Bezmialem Vakif University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 23, 2020

Study Start

February 1, 2019

Primary Completion

December 16, 2019

Study Completion

April 5, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

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

Locations

TU(1)