A double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of Ashwagandha and Selenium combination as a supplement in patients with subclinical hypothyroidism.

Sami Sabinsa Group Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

暂无简介。

•1. Male and Female participant age =18 and = 60 years
•2. Patients with serum T3, T4 within Normal Range but serum TSH to be more than Normal (= 4.6 µIU/mL - = 10 µIU/mL)
•3. Participant should be willing to provide a written and signed informed consent and comply with requirements of the trial.
•4. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.

•1. Patients under any allopathic or non-allopathic treatment for Subclinical or clinical hypothyroidism.
•2. Patients suffering from any other systemic illness viz. diabetes, HTN, liver disorders, cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor.
•3. Patients undergoing treatment for any other systemic illness.
•4. Patient who had Thyroid surgery or radioiodine therapy.
•5. Lactating Women & women of childbearing potential who are not willing to follow a reliable and effective contraceptive measure during the study.
•6. Patients with Polycystic ovary syndrome (PCOS).
•7. BMI =18.5 or =35 kg/m2.
•8. History of chronic smoking and Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
•9. Those who have participated in any other clinical trial within the last 3 months from the date of visit 1 or who plan to participate in any other study during the clinical trial period.
•10. Any other condition that the Principal Investigator thinks may jeopardize the study.

发起方