Health Condition 1: E038- Other specified hypothyroidism
Conditions
Interventions
None listed
Sponsors
Sandipani Healthcare Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 60 years, male or female 2. Diagnosis of subclinical hypothyroidism or mild hypothyroidism defined as: TSH must be between 4.5 and 10.0 mIUL, with or without normal free T3 and free T4. 3. On stable levothyroxine dose prior to screening, or treatment-na ve patients for whom SOC initiation is planned. 4. Presence of one or more thyroid-related symptoms such as fatigue, lethargy, stress, weight gain tendency, or reduced wellbeing. 5. Willingness to continue stable SOC dose throughout the study unless medically indicated 6. Ability to understand study procedures and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Overt or uncontrolled hypothyroidism or hyperthyroidism TSH More than 10mIUL. 2. Requirement for immediate levothyroxine dose adjustment at screening. 3. History of thyroid malignancy, thyroidectomy, or radioiodine therapy. 4. Severe or unstable autoimmune thyroid disease with recent flare. 5. Use of other thyroid-supporting herbal or nutraceutical products within 4 weeks prior to baseline. 6. Pregnant or lactating women, or women planning pregnancy. 7. Clinically significant cardiovascular, hepatic, renal, or psychiatric illness. 8. Known hypersensitivity to any ingredient of THYROBALANCE Juice. 9. Any condition that, in the Investigator s opinion, may compromise participant safety or study integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in serum Thyroid Stimulating Hormone TSH at Week 4, Week 8 and Week 12. 2. Change from baseline in free Triiodothyronine Free T3 and free Thyroxine Free T4 levels at Week 4, Week 8 and Week 12. Timepoint: 1. Baseline to Week 4, Week 8 and Week 12. 2. Baseline to Week 4, Week 8 and Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in overall thyroid-related symptom burden, as assessed by the ThyPRO Thyroid Specific Patient Reported Outcome questionnaire total score at Week 4, Week 8 and Week 12. 2. Change from baseline in body weight and Body Mass Index BMI 3. Change from baseline in Anti-TPO Antibodies, hs-CRP and Reverse T3 at week 12. 4. Proportion of participants achieving TSH normalization at Week 12. 5. Incidence and severity of treatment-emergent adverse events. Timepoint: 1. Baseline to Week 4, Week 8 and Week 12 2. Baseline to Week 4, Week 8 and Week 12 3. Baseline to Week 12 4. Baseline to Week 4, Week 8 and Week 12 5. AE monitoring throughout the study period baseline to week 12. | — |
Countries
India
Contacts
Public ContactMr Manoj Karwa
Sandipani Healthcare Pvt Ltd.
Outcome results
None listed