A Double Blind, Randomized, Placebo Controlled Clinical Study To Evaluate The Efficacy And Safety Of Tfn34 Tablets For Individuals With Subclinical And Clinical Hypothyroidism

Abstract

Hypothyroidism is one of the commonly presented medical complications addressed.There are Clinical symptoms that happens to differ from mild unspecific symptoms namely cold intolerance, tiredness, obstipation to life-threatening signs like myxedema&lack of vitality.The current study involved on designing as well as evaluating the clinical efficacy of the aforementioned prescription on poly-herbal formulation of oral medicationfor effective management of hypothyroidism. This study is planned to evaluate the efficacy and safety of TFN34 tablets for Individuals with subclinical & clinical hypothyroidism as assessed by clinical and laboratory methods including Zulewski Index questionnaire. Evaluating the treatment regime effect on hypothyroidism management and treatment that monitoring the level of FT3, FT4 and TSH is the secondary objective for identifying the compliance &AE to the study.The treatment regime comprised of administering TFN34 tablets which was developed with polyherbal formulation developed and manufactured by Apex Laboratories Private Limited, Chennai and the clinical trial was conducted at SRM Medical College Hospital & Research Centre,Kattankulathur.The clinical trial was intended to determine the efficacy &the safety of administering TFN34 tablets in the treatment and management of hypothyroidism cases among 60 patients by conducting a placebo controlled, randomized double blind study.