Clinical trial NCT04482907: Effect of Dill in Thyroiditis and Nodular Goiter Patients
Official title: Randomized Placebo Controlled Clinical Study of Anethum Graveolens L. (Dill) in Thyroiditis and Nodular Goiter Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodule
Keywords: Anethum graveolens L.
Thyroiditis
Nodular Goiter
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Comparison of thyroid stimulating hormone (TSH) between groups
timeFrame: 90 days
measure: Comparison of free triiodothyronine (fT3) between groups
timeFrame: 90 days
measure: Comparison of free thyroxine (fT4) between groups
timeFrame: 90 days
measure: Comparison of anti-thyroid peroxidase (anti-TPO) between groups
timeFrame: 90 days
measure: Comparison of anti-thyroglobulin (Anti-Tg) between groups
timeFrame: 90 days
measure: Comparison of C-reactive protein (CRP) between groups
timeFrame: 90 days
measure: Comparison of ultrasound and thyroid nodule sizes between groups
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fatih
country: Turkey
facility: Sabahattin Destek
state: Istanbul
Study officials:
affiliation: Bezmialem Vakif University
name: Ayşegul Yabacı, research
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.