Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
None listed
Sponsors
Abbott India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Sensitivity of Thyvox© test in terms of proportion of patient having positive Thyvox© test among the patients with hypothyroidism based on TSH, fT4 b. Specificity of Thyvox© test in terms of proportion of patient having negative Thyvox© test among the patients not having hypothyroidism based on TSH, fT4Timepoint: At the end of Screening visit | — |
Secondary
| Measure | Time frame |
|---|---|
| o To study the trends of SNR, F0 and formants in normalization of adult patients with primary hypothyroidismTimepoint: throughtout the study. | — |
Countries
India
Contacts
Public ContactSneha Nair
Abbott India Ltd
Outcome results
None listed