Arka dosage form of shweta Aparajita roots in management of Primary Hypothyroidism as add on along with Thyroxine.
- Conditions
- Health Condition 1: E039- Hypothyroidism, unspecified
- Registration Number
- CTRI/2024/07/070645
- Lead Sponsor
- Dr Jayshree Hadke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients between the age group of 25-50 years & of any Gender.
Patients who are already diagnosed as Primary Hypothyroidism and under Thyroxine
medication and within six months of Diagnosis and newly diagnosed cases.
Patients who are willing and sign the informed consent form.
Patient suffering from systemic disease like Cardiac Disorder/Diabetes
Mellitus/COPD/TB/HIV/HCV/HBsAg
Immuno-compromised patients.
Pregnancy and lactating mother and Renal insufficiency.
Patient who are known case of Congenital Hypothyroidism, Hypopitutarism, Secondary
Hypothyroidism, Thyroid, Neoplasia & Progressive cases of Myxedema coma.
Any serious medical and psychological condition will be excluded.
Malabsorption disorders
Concomitant use of drugs such as multivitamins, minerals, phenobarbital, phenytoin,
carbamazepine, rifampin, glucocorticoids, warfarin, statins, estrogen, and raloxifene.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Zulewski’s scoring <br/ ><br>ThyQoL <br/ ><br>Anthropometric measuresTimepoint: Clinical Assessment at <br/ ><br>baseline and monthly for 3 <br/ ><br>months. Lab test at base line <br/ ><br>and at the end of 3 months
- Secondary Outcome Measures
Name Time Method Free T3 <br/ ><br>Free T4 <br/ ><br>TSH <br/ ><br>Evaluation of TolerabilityTimepoint: Clinical Assessment at <br/ ><br>baseline and monthly for 3 <br/ ><br>months. Lab test at base line <br/ ><br>and at the end of 3 months