Effectiveness of individualized homoeopathic medicine on primary hypothyroidism with dyslipidemia while assessing the correlation between changes in serum TSH and total cholesterol levels: An open label, prospective, clinical study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- serum TSH & total cholesterol levels.
研究概览
简要总结
Null Hypothesis of the study is there is no significant role of individualized homoeopathic medicine in modifying the hypothyroid state with dyslipidaemia while assessing the correlation between changes in serum TSH and total cholesterol levels.
Alternative Hypothesis of the study is there is significant role of individualized homoeopathic medicine in modifying the hypothyroid state with dyslipidaemia while assessing the correlation between changes in serum TSH and total cholesterol levels.
With the aim to evaluate the effectiveness of individualized homoeopathic medicine on primary hypothyroidism with dyslipidemia while assessing the correlation between changes in serum TSH and total cholesterol levels.
With the objective to assess the effectiveness of individualized homoeopathic medicine on primary hypothyroidism with dyslipidaemia and to identify any correlation between changes in serum TSH levels and changes in serum total cholesterol levels in the age group of 12 to 65 years irrespective of gender.
A detailed case taking will be done using standard proforma of hypothyroid patients associated with dyslipidemia and serum TSH & total cholesterol levels are measured. The outcomes will be assessed initially at base line and after 6 months of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are diagnosed with primary hypothyroidism having serum TSH level more than 5mIU per L and total serum total cholesterol level more than 200mg per dl.
- •Patients aged between 12 to 65 years of all gender religions and socio economic status.
- •Patient who are willing to participate in the study and giving informed consent.
- •If patients taking any Homoeopathic or and Allopathic medicines for primary hypothyroidism and also willing to participate in the study, they will be enrolled in the study after washing period 2 months.
- •Patients who are willing to participate but illiterate then they will be enrolled after verbal explanation and consent, verified by the physicians signature and patients thumb impression.
排除标准
- •Patients having secondary hypothyroidism, congenital hypothyroidism and subclinical hypothyroidism.
- •Patients having primary dyslipidemia and secondary dyslipidemia associated of other causes.
- •Pregnant and lactating women.
- •Patients with habit of substance abuse and or dependence.
- •Patients having any psychiatric or life threatening illness or immune compromised state.
- •Patients taking any other substitutional treatment for primary hypothyroidism.
结局指标
主要结局
serum TSH & total cholesterol levels.
时间窗: Baseline and 6 months
次要结局
未报告次要终点
研究者
Dr Jyoti Bhushan Dash
National Institute of Homoeopathy