Thyroid Nodule Clinical Trial
— DillOfficial title:
Randomized Placebo Controlled Clinical Study of Anethum Graveolens L. (Dill) in Thyroiditis and Nodular Goiter Patients
Verified date | July 2020 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Sabahattin Destek | Fatih | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
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
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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