Non-inferiority Randomized Controlled Clinical Trial of the hormonal responses to Levothyroxin made by Aburaihan company and Levothyroxine made by Merck company

The study of clinical responses to Levothyroxine made by Abureihan versus Merck company

This clinical trial includes two groups of hypothyroid patients. The groups are double-blinded, parallel groups, and randomized. Phase 2 consists of 60 patients. Patients are divided into two groups based on cluster randomization

Patients will be recalled from a private clinic in Tehran to the Research Institute for Endocrine Sciences. The treatment will be allocated based on the pre-specified double-blinded random allocation while the researchers and patients are blinded to therapy. The drug will be continued for eight weeks. Participants will be evaluated for biochemical assessments, thyroid symptoms, and treatment satisfaction at baseline and end of the study.

Inclusion criteria: New patients with Hypothyroidism: serum TSH level should be 5.06-19.9 mIU/L and serum FT4 less than 0.91 ng/dL. Only new patients who have never taken thyroid treatment Exclusion criteria: Pregnant women People with underlying diseases such as liver failure, renal failure, heart failure People with co-factors that can simulate hypothyroidism symptoms: Low Hgb, Vitamin D and B12 deficiency, and Depression Taking any of the following medications during the trial: Methimazole, PTU, Tamoxifen, drugs containing Estrogen and Progesterone, Corticosteroid, Gastrointestinal medication

The first group consists of 30 patients with Hypothyroidism who receive Levothyroxine pills made by Merck. The treatment begins with 1.6 micro-gram per kg daily. The second group consists of 30 patients with hypothyroidism who will receive Levothyroxine pills made by the Abureihan company. The treatment begins with 1.6 micro-gram per kg daily.

The changes in serum TSH level and serum FT4 level, TSQ and THY-TSQ

Patients are divided into two intervention groups based on cluster randomization. Six stratifications will be made based on age and gender. At first, patients will be assigned to three age groups of ≤50y, 51-70y, and >70 y. Under each subgroup, patients will be assigned to male and female. Then under each sex subgroup, patients will be randomly assigned to two treatment groups using the random table. Random sequences will be generated using Random-Allocation software.

After performing randomization and special coding, subjects are assigned to groups using concealment, which helps keep physicians, participants, and researchers unaware of the type of treatment being assigned. Standard methods will be used to ensure concealment. Opaque containers will be numbered or coded in order. For single-center clinical trials such as the current trial, we select an expert who does not participate in the trial and can maintain a randomized list. This person is instructed to keep the list private and disclose treatment allocation only after receiving information indicating the patient is eligible and has consented to the trial. Subjects and researchers will be protected from knowing who will be assigned to which treatment (double-blind). Both groups will receive the same pills in appearance, taste, and smell.

These data belong to Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences.