Clinical study to evaluate the efficacy of thyroherb tablet in the management of primary hypothyroidism

A randomised open clinical trial to evaluate the efficacy of Thyroherb tablet in the management of primary hypothyroidism - nil

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063679

Enrollment

150

Registered

2024-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E05- Thyrotoxicosis [hyperthyroidism]

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.Therapeutic effect of Thyroherb in T3, T4 and TSH levels of Hypothyroid patients. 2.Significance of Thyroherb in improving the Quality of life in Hypothyroid patients. 3.Any incidents of adverse events after the administration of Thyroherb. 4.Any marked change in safety parameters measured during the administration of the product 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.	—

Measure

Time frame

1.Therapeutic effect of Thyroherb in T3, T4 and TSH levels of Hypothyroid patients. 2.Significance of Thyroherb in improving the Quality of life in Hypothyroid patients. 3.Any incidents of adverse events after the administration of Thyroherb. 4.Any marked change in safety parameters measured during the administration of the product 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

Measure	Time frame
1. Impact of Pharmacoeconomics in clinical management of Hypothyroidism. 2. Additional therapeutic advantages of the product. Timepoint: Day 1 and end of the study	—

Countries

India

Contacts

Public ContactDr Shan Sasidharan

Pankajakasthuri Herbal Research Foundation

drshan@pkhil.com09188325339

Outcome results