Evaluation of the Effect of Carum Carvi on Levels of Plasma Thyroid Hormones and TSH Level in Patients on Thyroid Hormone Therapy and Normal Controls.
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks
研究概览
简要总结
Carum Carvi has been frequently used in traditional medicine for a variety of disease ranging from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients with thyroid cancer who receiving Carum Carvi despite being on suppressive dose of levothyroxin. TSH level returned to normal after discontinuation of the Carum carvi. This observation led to a pilot study for evaluation of the effect of carum carvi on thyroid function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65
- •Hypothyroid patients under treatment with levothyroxin
- •Normal euthyroid patients with no goiter
排除标准
- •Pregnancy or lactation
- •Severe lung or gasterointestinal disease
- •Heart failure or renal failure
研究组 & 干预措施
Group3
Normal controls
干预措施: Carum Cravi (Drug)
Group4
Normal controls
干预措施: Placebo (Drug)
Group 1
Hypothyroid patients taking levothyroxin.
干预措施: Carum Cravi (Drug)
Group2
Hypothyroid patients taking levothyroxin
干预措施: Placebo (Drug)
结局指标
主要结局
Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks
时间窗: 0-2-6 Weeks
TSH, Free T4, Free T3, T4RIA and T3RIA
次要结局
- Change of hypothyroidism index from baseline at 2 and 6 weeks(0,2 and 6 weeks)