To Evaluate the Efficacy and Safety of thyroid capsule in the Management of Subclinical Hypothyroidism- An Open Label Clinical Studyâ??
- Conditions
- Health Condition 1: E02- Subclinical iodine-deficiency hypothyroidism
- Registration Number
- CTRI/2019/12/022481
- Lead Sponsor
- The Himalaya Drug Company Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Subjects of both sex aged >= 18 years to <= 65 years
Subjects untreated with Subclinical hypothyroidism SH defined as persistently elevated TSH levels between >=4.5 - <=10.0 mU/l) and may or may not be associated with T3 (80 to 200 ng/dL) free T3(2.3 to 4.2 pg/mL), T4 4.5-12.5 µg dL free T40.8 1.8 ng dL
Subjects presenting with one or more of the following clinical symptoms such as anxiety weakness fatigue sleepiness cold intolerance hoarseness of voice hair loss constipation joint pains and muscle cramps depression menorrhagia infertility weight gain
Subjects willing to give written informed consent.
Subjects who have not participated in similar kind of study in last 2 months
Subjects current on levothyroxine anti thyroid drugs amiodarone or lithium
Subjects with any clinically significant systemic illnesses including any chronic untreated gastrointestinal disorder
Grade IV NYHA Heart failure
Hospitalization for major illnesses elective surgery or acute coronary syndrome MI or unstable angina within 4 weeks
Acute Myocarditis
Clinical diagnosis of dementia
Untreated adrenal insufficiency
Pregnant & lactating women are excluded
Subjects not willing to sign informed consent form
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the Efficacy and safety of Thyroid regulator in individuals suffering from Subclinical HypothyroidismTimepoint: At entry. End of 1st month End of 2nd month and end of 3rd month EOS.
- Secondary Outcome Measures
Name Time Method Compliance of the subject to the intervention and assessment of adverse effects reported or observed during the study period.Timepoint: At entry visit. End of 1st month. End of 2nd month and End of 3rd month EOS.