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

Primary Purpose

Thyroid Nodule

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Nodule focused on measuring Anethum graveolens L., Thyroiditis, Nodular Goiter

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sabahattin Destek

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group receiving dill

Group receiving placebo

Arm Description

They took 3 meals a day, 3x300 mg dry dill powder by mouth. They bought dry dill powder for 90 days.

They took 3 meals a day and 3 cellulose placebo capsules by mouth. They took placebo capsules for 90 days.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2020
Last Updated
July 20, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04482907
Brief Title
Effect of Dill in Thyroiditis and Nodular Goiter Patients
Acronym
Dill
Official Title
Randomized Placebo Controlled Clinical Study of Anethum Graveolens L. (Dill) in Thyroiditis and Nodular Goiter Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
April 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
Keywords
Anethum graveolens L., Thyroiditis, Nodular Goiter

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group receiving dill
Arm Type
Active Comparator
Arm Description
They took 3 meals a day, 3x300 mg dry dill powder by mouth. They bought dry dill powder for 90 days.
Arm Title
Group receiving placebo
Arm Type
Placebo Comparator
Arm 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(s)
Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.
Other Intervention Name(s)
Taking blood from the arm intravenously at the beginning and end of the study and looking for thyroid hormones from this blood.
Intervention Description
Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP
Primary Outcome Measure Information:
Title
Comparison of thyroid stimulating hormone (TSH) between groups
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.
Time Frame
90 days
Title
Comparison of free triiodothyronine (fT3) between groups
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.
Time Frame
90 days
Title
Comparison of free thyroxine (fT4) between groups
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.
Time Frame
90 days
Title
Comparison of anti-thyroid peroxidase (anti-TPO) between groups
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.
Time Frame
90 days
Title
Comparison of anti-thyroglobulin (Anti-Tg) between groups
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.
Time Frame
90 days
Title
Comparison of C-reactive protein (CRP) between groups
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.
Time Frame
90 days
Title
Comparison of ultrasound and thyroid nodule sizes between groups
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşegul Yabacı, research
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Chair
Facility Information:
Facility Name
Sabahattin Destek
City
Fatih
State/Province
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
When published as a full article in a journal indexed, IPD will be shared.
Citations:
PubMed Identifier
22228959
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.
Results Reference
result
PubMed Identifier
23764360
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.
Results Reference
result
PubMed Identifier
25461470
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.
Results Reference
result
PubMed Identifier
24908232
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.
Results Reference
result
PubMed Identifier
29215302
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.
Results Reference
result
PubMed Identifier
27753646
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.
Results Reference
result

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Effect of Dill in Thyroiditis and Nodular Goiter Patients

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