Clinical study to evaluate the efficacy of thyroherb tablet in the management of primary hypothyroidism
- Conditions
- Health Condition 1: E05- Thyrotoxicosis [hyperthyroidism]
- Registration Number
- CTRI/2024/03/063679
- Lead Sponsor
- Pankajakasthuri Herbals India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of either gender in the age group between 18 to65 years
2.T3 less than 0.97 ng/mL or T4 less than 5.53 ng/mL or TSH greater than 4.049 ng/mL
3.Patients eligible having Symptoms of Hypothyroidism with minimum 3-6 months duration
4.Willing to enrol in study by signing Informed consent.
1.Earlier participation in similar clinical trials.
2.Patients with secondary Hypothyroidism.
3.Patients having other systemic diseases not under control.
4.Patients who are not willing to sign the informed consent form
5.Patients who are diagnosed with malignancies, autoimmune diseases, complications
of Hypothyroidism, Temporary hypothyroidism, acute onset disorders like Hashimoto’s Thyroiditis.
6.Patients who have undergone any type of thyroid surgery.
7.Patients who are on corticosteroid therapy.
8.Subjects who are pregnant, breast feeding and those who plan to conceive within the trial period.
9.Patients of special category population.
10.Unable to respond properly for questionnaire or when a patient is too severely ill to answer the questions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Therapeutic effect of Thyroherb in T3, T4 and TSH levels of Hypothyroid patients. <br/ ><br>2.Significance of Thyroherb in improving the Quality of life in Hypothyroid patients. <br/ ><br>3.Any incidents of adverse events after the administration of Thyroherb. <br/ ><br>4.Any marked change in safety parameters measured during the administration of the product <br/ ><br>Timepoint: Measure TSH, T3, and T4 levels at each follow-up visit to assess changes from baseline on 45th day,90th day and 135th day.
- Secondary Outcome Measures
Name Time Method 1.Impact of Pharmacoeconomics in clinical management of Hypothyroidism. <br/ ><br>2.Additional therapeutic advantages of the product. <br/ ><br>Timepoint: Day 1 and end of the study