None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult males and females of ages >= 18 years and 2.Patients who can and willing to provide written Informed Consent. 3.Patients with diagnosis based on persistently elevated TSH levels (4.6â??10.0â??mU/L), with fT4 within the reference range. 4. Participant who agree to take Investigational product (IP) till Day 56. 5. Patients having capability of complete compliance and completion of followup . 6. Participant / participantâ??s legally acceptable representative understands and can comply with clinical trial protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients Ë? 18 years or Ë? 60 years of age. 2.Patients on current prescription of levothyroxine, antithyroid drugs, amiodarone, or lithium 3.Patients having a history or presence of clinically relevant cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor. 4.Patients with severe mental disorder. 5.Patients with recent thyroid surgery or radioiodine therapy within 1-year of the start date of the study. 6. Patients with recent hospitalization for major illness or elective surgery within 1- year of the start date of the study. 7.Female patients with pregnancy or lactation, intention to become pregnant, and/or not using appropriate contraceptive methods. 8.Patients with terminal illness. 9.Patients with history of alcoholism or substance abuse. 10. Patients who are not willing to take investigational product. 11. Patients on dietary supplements/multivitamins or disease-specific oral nutrition supplements. 12. Patients with uncontrolled, unstable comorbidities. 13. Patients with pre-existing respiratory conditions or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease. 14. Patients taking part in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements. 15. Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled, unstable comorbidities. 16. Patients who had participated in other clinical trials during previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Standard TSH, T3, T4Timepoint: Baseline and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in SF 12 (QoL) between baseline and end of treatment. 2.Change in QoL-THY between baseline and end of treatment 3.Change in PSQI between baseline and end of treatment. 4.Change in MMSE score between baseline and end of treatment. 5.Severity of AEs between groups. 6.Frequency of AEs between groups. 7.Patientâ??s Global Assessment of Tolerability to Therapy (PGATT).Timepoint: Baseline and Day 56 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed