A Randomized, Parallel Arm Trial Evaluating Thyphy as an Adjunct Intervention for Maintaining Euthyroid Status During Levothyroxine Tapering
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Maintenance of Euthyroid Status in participants during Levothyroxine tapering by measuring TSH, FT3 & FT4.
研究概览
简要总结
Hypothyroidism is commonly treated with lifelong levothyroxine therapy. However, a subset of patients maintained on low doses of levothyroxine may be able to sustain normal thyroid function with appropriate supportive interventions. This Phase-2, single-arm clinical study aims to evaluate the effectiveness and safety of ThyPhy for Balance, a plant-based nutritional intervention, in maintaining euthyroid status during a structured tapering of levothyroxine leading to reversal of hypothyrodism.
Adult patients with primary hypothyroidism who are clinically and biochemically euthyroid on a stable levothyroxine dose of not more than 50 mcg/day will be enrolled. Participants will undergo a stepwise reduction of levothyroxine over a period of 3 months (90 days) while receiving ThyPhy for Balance as an adjunct intervention. Thyroid function will be closely monitored throughout the study.
The primary outcome of the study is the proportion of participants who maintain biochemical euthyroidism (normal TSH and free T4 levels) at the end of the tapering period. Secondary outcomes include the extent of levothyroxine dose reduction achieved, changes in thyroid hormone parameters, symptom burden, quality of life, and safety outcomes.
This study is designed to generate proof-of-concept evidence on whether ThyPhy for Balance can support endogenous thyroid function and reduce dependency on exogenous levothyroxine in patients leading to reversal of hypothyroidism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female adults aged 18–65 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.
排除标准
- •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.
结局指标
主要结局
Maintenance of Euthyroid Status in participants during Levothyroxine tapering by measuring TSH, FT3 & FT4.
时间窗: Day 0, 30, 60 & 90
Laboratory Parameters like Serum TSH, FT3 & FT4 within laboratory reference range without the need for rescue escalation of levothyroxine dose.
时间窗: Day 0, 30, 60 & 90
次要结局
- 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 memory(Day 0, 30, 60 & 90)
研究者
Dr Ragavendra Pandilwar
Dr. G. D. POL Foundation Y. M. T. Ayurvedic Medical College and Hospital