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NCT04795947
Correlation Between Thyroid Function and Quality of Life in Hypothyroidism
trial testing Behavioral in Hypothyroidism in 98 participants. Status unknown.
1 November 2021
Quick facts
| Lead sponsor | Beijing Chao Yang Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 98 |
| Start date | 1 November 2020 |
| Primary completion | 1 November 2021 |
| Estimated completion | 1 November 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Behavioral
Conditions studied
- Hypothyroidism — all drugs for Hypothyroidism →
Sponsor
Beijing Chao Yang Hospital
Who can join
Adults 18 to 75, any sex, with Hypothyroidism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
According to the prevalence survey of thyroid diseases in ten cities in China in 2010, TSH\>4.2 mIU /L was the diagnostic cut-off point, and the prevalence of hypothyroidism was 17.8%, including 1.1% clinical hypothyroidism.The annual incidence of hypothyroidism in China is 2.9‰, and primary hypothyroidism is the most common.Typical patients have chilliness, fatigue, swelling of hands and feet, lethargy, memory loss, hypoperspiration, joint pain, weight gain, constipation, menstrual disorder or menorrhagia, infertility, which affects the physiological and psychological functions of patients and reduces the quality of life of patients.The treatment goal of primary clinical hypothyroidism is that the symptoms and signs of hypothyroidism disappear, and TSH, TT4 and FT4 values remain in the normal range.Levothyroxine (L-T4) is the main alternative therapy for this disease.Thyroid disease patients quality of life questionnaire (Thyroid - specific Patient Reported Outcome, ThyPRO) for the development of the Danish scholars such as WATT first can be applied to various comprehensive scale of benign Thyroid disease patients, applied in the Danish people has good reliability and validity, has been translated into ten languages application in many countries the crowd, WATT et al in 2015 developed the scale of the concise version (ThyPRO39).Studies have shown that in the treatment of patients with thyroid disease, even if thyroid function is within the normal range, there are still physiological or psychological impairments such as chills, fatigue, anxiety, depression, which reduces the quality of life of patients.Studies have shown that TSH level in patients with hypothyroidism is correlated with patients' quality of life. Even within the normal range, the higher TSH level is, the worse the patients' quality of life score is, and there is an independent correlation in fatigue and emotional susceptibility. This study except for other factors, such as merger disease with primary hypothyroidism patients quality of life assessment, observe the normal JiaJian patients, we use the current widely used thyroid disease patients to evaluate the quality of life questionnaire (ThyPRO - 39), observe thyroid hormone levels in patients with hypothyroidism and their quality of life scale and the relevance of the blood sugar, blood lipid metabolic indicators related to relevance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04795947 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Chao Yang Hospital
- Last refreshed: 12 March 2021
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