Health Condition 1: E039- Hypothyroidism, unspecified
Conditions
Interventions
Intervention1: ThyPhy for Balance: Both Groups will consume ThyPhy for Balance alongwith
Thyroxine medication empty stomach every morning for a period of 3 months
Control Intervention1: LevoThyroxine
Sponsors
Arelang Naturals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female adults aged 18â??65 years. Clinical diagnosis of primary hypothyroidism on stable levothyroxine replacement for less than equal to 6 months with no dose change in the last 3 months. Current levothyroxine dose not more than 50 µg/day (NMT 50 µg) at screening. Biochemically euthyroid at screening: TSH within local lab reference range and free T4 within reference range (drawn on stable dose). Willingness to start and adhere to ThyPhy for Balance dosing regimen and to follow the taper schedule. Able to give written informed consent and comply with study procedures and follow-up. If female and of childbearing potential: negative pregnancy test at screening and agreement to use reliable contraception for study duration.
Exclusion criteria
Exclusion criteria: Overt Hypothyroidism Patient taking thyroxine dosages more than 50 mcg History of thyroid surgery or radioactive iodine treatment Uncontrolled chronic diseases (e.g., uncontrolled diabetes, cardiovascular disorders, renal or hepatic impairment) Pregnant or lactating women Diagnosed psychiatric or neurological conditions interfering with study compliance History of allergy to any components of the investigational product Participation in another clinical trial within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance of Euthyroid Status in participants during Levothyroxine tapering by measuring TSH, FT3 & FT4. Laboratory Parameters like Serum TSH, FT3 & FT4 within laboratory reference range without the need for rescue escalation of levothyroxine dose.Timepoint: Day 0, 30, 60 & 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the subjective criteria which includes: Weight gain, Lethargy & Fatigue, Constipation, Puffiness of Face,Amenorrhea, Hair loss, Skin Dryness, Hoarseness of voice, Cold Intolerance, Slowed Movement, Difficulty concentration and poor memoryTimepoint: Day 0, 30, 60 & 90 | — |
Countries
India
Contacts
Public ContactShefali Thakkar
Arelang Naturals Pvt. Ltd.
Outcome results
None listed