Health Condition 1: E02- Subclinical iodine-deficiency hypothyroidism
Conditions
Interventions
Intervention1: Ashwagandha 500mg & Selenium 40mcg: one capsule once a day after dinner for 90 Days
Control Intervention1: 500 mg of Microcrystalline cellulose.: One Capsule once a day after dinner for
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in Serum TSH levels. Timepoint: 1. Screening Visit to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in Serum T3 levels. 2. Mean change in Serum T4 levels 3.Mean change in anti-thyroid peroxidase antibody 4.Mean change in Lipid Profile 5.Mean change in BMI 6.Safety as determined through changes in complete blood count (CBC) blood biochemistry tests results & incidence of adverse events during the study period in both arms.Timepoint: 1. Screening Visit to Day 90 2. Screening Visit to Day 90 3. Day 0 to Day 90 4. Screening Visit to Day90 5. Day 0 & Day 90 6. Screening to Day90 | — |
Countries
India
Contacts
Public ContactSatish G
Sami-Sabinsa Group limited
Outcome results
None listed