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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04482907
Other study ID # 12.2014/21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date April 5, 2020

Study information

Verified date July 2020
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date April 5, 2020
Est. primary completion date December 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Sabahattin Destek Fatih Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. Review. — View 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. — View Citation

Krátký J, Vítková H, Bartáková J, Telicka Z, Antošová M, Límanová Z, Jiskra J. Thyroid nodules: pathophysiological insight on oncogenesis and novel diagnostic techniques. Physiol Res. 2014;63 Suppl 2:S263-75. Review. — View 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. 2 — View 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 201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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