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An observational study to assess proportion of hypothyroid patients having out-of-range serum TSH values despite being on treatment and to probe reasons for the same

A cross-sectional, observational study to assess proportion of primary hypothyroid patients having out-of-range serum TSH values despite being prescribed thyroxin and to probe reasons for the same - TISOT study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2011/12/002219
Enrollment
2000
Registered
2011-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Hypothyroidism

Interventions

None listed

Sponsors

Abbott India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender, aged more than or equal to 18 years and less than or equal to 60 years diagnosed with primary hypothyroidism. 2. Currently on treatment with any brand of levothyroxin for at least 3 months and on a stable dose of thyroxin for at least 2 months prior to enrolment. 3. Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients receiving tri-iodothyronine (T3) as monotherapy or in combination with levothyroxin 2. Patients who are mentally retarded or unable to communicate 3. Patients with central hypothyroidism 4. Patients where hypothyroidism is likely to be transient 5. Pregnant and lactating women 6. Participating in any other clinical study

Design outcomes

Primary

MeasureTime frame
1.To assess percentage (%) of primary hypothyroid patients with abnormal thyroid function (measured using serum TSH level as surrogate marker of thyroid function) despite being prescribed levothyroxin for at least 2 months prior to enrolment in clinical practice among physicians across IndiaTimepoint: NA

Secondary

MeasureTime frame
1. To assess reasons for out-of range serum TSH values which could be: a. Presence of confounding factors (age, etiology of hypothyroidism, concomitant medication and illness etc.) and failure to adjust thyroxin dose for such confounders b. Poor compliance on part of patients Timepoint: NA;2. To assess their quality of life Timepoint: NA

Countries

India

Contacts

Public ContactDr Sakharam Garale

Abbott India Limited

neeraj.tewari@abbott.com91-22-67978876

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026