CTRI/2019/05/019165Other未知
A Phase IV, Observational, Multicenter Study to Determine the Accuracy of Thyvox© (Acoustic Biomarker) as a screening tool for Primary Hypothyroidism in Adult Patients & to identify the correlation between voice change and Thyroxine Sodium treatment - LEVT4001
试验速览
- 阶段
- 未知
- 状态
- Other
- 入组人数
- 97
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male or female patients 18-65 years of age
- •2. For sensitivity group: Patients suspected to have hypothyroidism as per physicianâ??s clinical judgement (such as patients presenting with weakness, skin changes, lethargy, hoarseness of voice, slow speech, eyelid edema, cold sensation, decreased sweating, cold skin, thick tongue, facial edema, coarse hair, skin pallor, forgetfulness, constipation etc.)
- •3. For Specificity group: Patients who are not suspected of hypothyroidism
- •4. Patients willing to sign an Informed consent form prior to any study procedure
排除标准
- •1. Patients with primary hypothyroidism who are already on treatment with Thyroxine Sodium
- •2. Pregnant and/or lactating women
- •3. Patients with history of throat and vocal fold disease, head and neck surgery, or head and neck trauma
- •4. Patients with any acute or chronic systematic illnesses that in the opinion of the investigator does not justify the patientâ??s inclusion in the study
研究者
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