effect of combination therapy of levothyroxine and levothyronine in comparison with levothyroxine in quality of life and cognitive function of patients with primary hypothyroidism
- Conditions
- Hypothyroidism.Other hypothyroidism
- Registration Number
- IRCT20200410047012N1
- Lead Sponsor
- Gorgan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 158
Age over 16 years
Being able to read and understand Persian
Diagnosis of overt hypothyroidism at least 6 months before inclusion
Stable and regular LT4 monotherapy for at least 3 months before
Patient-reported signs and symptoms of hypothyroidism including fatigue, mood change, weight gain, lethargy, decreased psychomotor performance conative, depression, and disturbances despite normal thyroid hormone levels
Pregnancy or planned pregnancy within the next 6 months
Patients with drug or alcohol addiction
Patients with Malignancy
Patients with cardiovascular disease
Patients with renal, or hepatic disease
Patients with chronic liver disease
Patients with depression, anxiety
Patients with mental illness and had been on psychiatric medicine for 6 months before inclusion
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The quality of life changes between baseline and follow-up visits of the Physical component summary in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire.;The quality of life changes between baseline and follow-up visits of the Mental component summary in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire.
- Secondary Outcome Measures
Name Time Method