Effects on thyroid function of a supplement containing: Ashwagandha, Guggul, Magnesium, L-Tyrosine, L-Glutamine, Zinc, Resveratrol, Manganese, Copper, Folic acid, Selenium, Iodine, and Vitamin B12.
Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of a Novel Nutraceutical based on Ashwagandha and Guggul, in subjects with Subclinical Hypothyroidism.
Hellenic Endocrine Network
80 participants
Jun 30, 2025
Interventional
Conditions
Summary
We are planning to test the efects of a novels suplament for the functionality of the thyroid gland, based on a Ashwagandha, Guggul, Magnesium, L-Tyrosine, L-Glutamine, Zinc, Resveratrol, Manganese, Copper, Folic acid, Selenium, Iodine and Vitamin B12. Iodine contributes to the normal production of thyroid hormones and normal thyroid function. Selenium contributes to the normal thyroid function. Magnesium, Copper and Vitamin B12 contributes to normal energy-yielding metabolism. Zinc contributes to the protection of cells from oxidative stress, to normal acid-base metabolism, to normal carbohydrate metabolism, to normal macronutrient metabolism, to normal metabolism of fatty acids, to normal metabolism of vitamin A. Manganese contributes to the protection of cells from oxidative stress.
Eligibility
Inclusion Criteria1
- Patients with TSH levels between 4 and 8 mU/I, Free- T4 levels within normal rang (0.9 – 1.7 ng/dL) and increased titers of antithyroid antibodies: Thyroid peroxidase antibodies (TPOAb) and/or Thyroglobulin antibodies (Tg Ab).
Exclusion Criteria6
- individuals who have been taking thyroxin before the study.
- Medications affecting thyroid function: individuals who are taking medications known to interfere with thyroid function or can alter thyroid function tests, such as anticonvulsants, non-steroidal anti-inflammatory drugs, beta-adrenoceptor antagonists, steroid hormones, amiodarone, and heparin.
- Individuals taking supplements containing iodine or biotin.
- Other metabolic disorders: individuals with specific metabolic disorders that could impact thyroid function metabolism or lead to altered thyroid tests, such as chronic renal and liver disease.
- Pregnancy and breastfeeding
- Severe illnesses or comorbidities: terminal cancer, uncontrolled diabetes, or autoimmune disorders.
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Interventions
Randomsied, placebo controlled trial. One interventional arm and one placebo/comparator arm. Participants are randomised to treatment arm or placebo.The study is parallel in design. Arm 1: Nutraceutical containing: Ashwagandha, Guggul, Magnesium, L-Tyrosine, L-Glutamine, Zinc, Resveratrol, Manganese, Copper, Folic acid, Selenium, Iodine, and Vitamin B12,taken once daily for 12 weeks via two oral tablets. Arm 2: Nutraceutical Placebo once daily for 12 weeks via two oral tablets Adherence to therapy : tablet return at the end of the study. For additional notes on placebo tablets, please see section below.
Locations(1)
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ACTRN12625000561482