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临床试验/NCT04482907
NCT04482907已完成不适用

Randomized Placebo Controlled Clinical Study of Anethum Graveolens L. (Dill) in Thyroiditis and Nodular Goiter Patients

Bezmialem Vakif University2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Comparison of free triiodothyronine (fT3) between groups

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 76 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Comparison of free triiodothyronine (fT3) between groups

时间窗: 90 days

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 thyroid stimulating hormone (TSH) between groups

时间窗: 90 days

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 anti-thyroglobulin (Anti-Tg) between groups

时间窗: 90 days

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

时间窗: 90 days

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 free thyroxine (fT4) between groups

时间窗: 90 days

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

时间窗: 90 days

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 ultrasound and thyroid nodule sizes between groups

时间窗: 90 days

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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