CTRI/2019/12/022481招募中2 期
To evaluate the efficacy and safety of HTYR091524 capsule in the management of Subclinical Hypothyroidism- An Open Label Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects of both sex aged >= 18 years to <= 65 years
- •Subjects untreated with Subclinical hypothyroidism SH defined as persistently elevated TSH levels between >=4.5 - <=10.0 mU/l) and may or may not be associated with T3 (80 to 200 ng/dL) free T3(2.3 to 4.2 pg/mL), T4 4.5-12.5 µg dL free T40.8 1.8 ng dL
- •Subjects presenting with one or more of the following clinical symptoms such as anxiety weakness fatigue sleepiness cold intolerance hoarseness of voice hair loss constipation joint pains and muscle cramps depression menorrhagia infertility weight gain
- •Subjects willing to give written informed consent.
- •Subjects who have not participated in similar kind of study in last 2 months
排除标准
- •Subjects current on levothyroxine anti thyroid drugs amiodarone or lithium
- •Subjects with any clinically significant systemic illnesses including any chronic untreated gastrointestinal disorder
- •Grade IV NYHA Heart failure
- •Hospitalization for major illnesses elective surgery or acute coronary syndrome MI or unstable angina within 4 weeks
- •Acute Myocarditis
- •Clinical diagnosis of dementia
- •Untreated adrenal insufficiency
- •Pregnant & lactating women are excluded
- •Subjects not willing to sign informed consent form
研究者
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