A Double Blind Randomized Placebo Controlled Clinical Study to Evaluate the Efficacyand Safety of TFN34 tablets for Individuals with Subclinical and Clinical Hypothyroidism

Apex Laboratories Private Limited Research and Development Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•Subjects with TSH Value greater than or equal to 4.5
•? Individual presenting with at least four of the symptoms like Fatigue, cold
•intolerance, Constipation, Dry rough & pale skin, Weight gain, Puffiness of face,
•Hoarseness, Muscle weakness, Muscle cramps and frequent muscle aches, Abnormal
•menstrual cycle, Dry, coarse thinning of hair, Hair loss, Slowed heart rate,
•Depression, Irritability, Impaired memory, Decreased libido.
•? Subjects willing to sign informed consent and follow the study procedure.
•? Has not participated in a similar investigation in the past four weeks.

•Subjects currently on levothyroxine, anti-thyroid drugs, amiodarone or lithium.
•Subjects with any clinically significant and uncontrolled systemic illnesses
•(including Gastrointestinal, Cardiac, Neurological, Respiratory, Immunological or
•endocrinological disorder) as judged by the investigator, which can hamper the
•participation of subjects in clinical study.
•? Hospitalization for major illnesses/ elective surgery within 4 weeks
•Clinical diagnosis of any psychiatric or psychological disorders rendering the subject
•not to follow the study procedures.
•Pregnant or lactating women or women of child bearing potential not willing to use
•the established measures of of contraception.

发起方

Apex Laboratories Private Limited Research and Development Centre