Assessing the efficacy of individualised homoeopathic remedies on the TSH levels and Billewicz scale in the treatment of hypothyroidism cases: A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment will be based on the changes in the TSH levels, T3 and T4 levels and Billewicz scoring index.
研究概览
简要总结
This study aims to assess the effectiveness of individualized homoeopathic remedies in improving thyroid function in patients diagnosed with hypothyroidism. Hypothyroidism is a common condition where the thyroid gland fails to produce sufficient thyroid hormones, leading to symptoms such as tiredness, weight gain, dry skin, and depression. While conventional treatment with Levothyroxine is the standard, it often requires lifelong use and may cause side effects.
In this randomized controlled trial, 80 participants between the ages of 18 and 50, recently diagnosed with hypothyroidism and already receiving Levothyroxine, were divided into two groups. One group received individualized homoeopathic medicines along with Levothyroxine (Group A), while the other received a placebo alongside Levothyroxine (Group B). The participants were monitored over a period of time using two key outcome measures: the levels of Thyroid Stimulating Hormone (TSH) in the blood, and clinical assessment using the Billewicz scoring system, a standardized tool to evaluate hypothyroidism symptoms.
The study seeks to explore whether individualized homoeopathic treatment can contribute to better management of hypothyroidism by reducing TSH levels and improving clinical symptoms, thereby offering a gentler, more holistic approach alongside conventional care.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who provide informed consent, regardless of their socio-economic status, religion, or occupation.
- •Subjects diagnosed with hypothyroidism within the past one year, having a TSH level greater than 5.0 micro-IU per mL, and currently receiving Levothyroxine therapy.
- •Subjects with a Body Mass Index ranging between 18.5 and 24.9 kg per m².
排除标准
- •Subjects diagnosed with secondary hypothyroidism.
- •Subjects with known chronic systemic illnesses, such as diabetes mellitus, hypertension, or polycystic ovarian syndrome, are currently undergoing active treatment.
- •Expectant mothers, pregnant women, and lactating mothers.
- •Subjects presenting with complications of hypothyroidism, including myxoedema coma or cardiovascular disease.
结局指标
主要结局
Assessment will be based on the changes in the TSH levels, T3 and T4 levels and Billewicz scoring index.
时间窗: baseline thereafter end of every 6th month for 1 year
次要结局
未报告次要终点
研究者
Dr Thrupthi S
BVVS Homeopathic Medical College and Hospital.