Clinical study to evaluate the effect of Shakotaka Taila nasal drops with Krimighnadi Kashaya and Phalatrikadi Kashaya orally in the management of Primary Hypothyroidism with Obesity
- Conditions
- Health Condition 1: E039- Hypothyroidism, unspecifiedHealth Condition 2: E038- Other specified hypothyroidism
- Registration Number
- CTRI/2024/07/069901
- Lead Sponsor
- Dr Shruthi Shivarama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subjects fulfilling the diagnostic criteria.
Both fresh and treated cases of hypothyroidism will be included.
Freshly detected and untreated cases of hypothyroidism.
Established and treated cases of hypothyroidism also who are ready to discontinue the earlier medication with Flush out period of 15 days.
Patients with hypothyroidism BMI more than 25.
Subjects with serum TSH more than 5 to less than 10 ml IU/L and more than 10ml Primary Hypothyroidis with decrease fT4 and fT3.
Who signed the informed consent.
Subjects with congenital hypothyroidism, chronic history of hypothyroidism more than 5 yrs and secondary hypothyroidism or tertiary hypothyroidism.
subjects with any chronic systemic disorders like cerebrovascular accidents, ischemic heart diseases, uncontrolled diabetes mellitus, uncontrolled hypertension, any active malignancies, chronic renal failure, radiation therapy etc which interrupt the present intervention.
Subjects who have undergone thyroid surgery.
Pregnant and lactating women.
Diagnosed cases of neoplastic conditions, toxic goiter, drug induced hypothyroidism will also be excluded.
Who doesn’t sign the informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pratimarsha nasya with Shakotaka Taila and Krimighnadi Kashaya efficacy in treating primary hypothyroidism with obesity <br/ ><br> <br/ ><br>assessing improvement with with diagnostic criteria- <br/ ><br>Thyroid profile (Serum)TSH, fT3, fT4 and TPO-ab. <br/ ><br>Waist circumference <br/ ><br>waist hip ratio <br/ ><br>Subjective criteria- <br/ ><br>Clinical signs and symptoms <br/ ><br>Zulewski’s clinical score for hypothyroidism. <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 1st Initial Assessment- 0th day <br/ ><br>2nd Assessment - 30th day <br/ ><br>3rd Assessment - 61st day <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Establishing a safe, effective, non levothyroxine hormone supplement dependent formulation in the management of Hypothyroidism with Obesity. <br/ ><br> <br/ ><br>2. Establishing whether intervention is improving the quality of life of Hypothyroidism with Obesity <br/ ><br>Timepoint: 1st Initial Assessment- 0th day <br/ ><br>2nd Assessment - 30th day <br/ ><br>3rd Assessment - 61st day <br/ ><br>