CLINICAL TRIAL TO EVALUATE THE EFFECT OF TRIKATU IN SUBCLINICAL HYPOTHYROIDISM
- Conditions
- Health Condition 1: E039- Hypothyroidism, unspecified
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
a.Patients of either sex with age between 18 and 60 years.
b.Freshly diagnosed Patients of subclinical Hypothyroidism with elevated TSH levels between 5.5-10uIU/ml with normal T4 value.
c.Patients, willing to give written informed consent to participate in the study
a.TSH levels >10uIU/ml
b.Patients who have undergone any type of thyroid surgery.
c.Patients with uncontrolled Diabetes mellitus (HbA1C >8%).
d.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.4 mg/dl)
e.Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
f.Patients with poorly controlled hypertension ( >= 160/100 mmHg)
g.Patients who are under treatment for any thyroid disorder
h.Hypertensive patients who are on β blockers.
i.Symptomatic patients with clinical evidence of Heart failure.
j.Alcoholics and/or drug abusers.
k.H/o hypersensitivity to any of the trial drugs or their ingredients.
l.Pregnant/lactating woman.
m.Patients who are currently enrolled in any other clinical trial.
n.Any other condition which the Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Change in Signs and symptoms. <br/ ><br>â?¢Reduction in TSH <br/ ><br>Timepoint: 84 days
- Secondary Outcome Measures
Name Time Method FT, RFT and adverse drug reaction for safety assessmentTimepoint: 84 days