Randomized Controlled Trial on effect of Takrarishta in Subclinical Hypothyroidism.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- i)To decrease the serum TSH level in Subclinical Hypothyroidism after oral administration of Takrarishta for 60 days.
研究概览
简要总结
Subclinical hypothyroidism (also known as compensated hypothyroidism or mild hypothyroidism) is a condition associated with a raised serum concentration of thyroid stimulating hormone (TSH) but a normal serum free thyroxine (FT4). It is common, affecting about 10% of women above the age of 55 years. Autoimmunity is the commonest cause of subclinical hypothyroidism. About 2.5% of patients with subclinical hypothyroidism progress to clinically overt hypothyroidism each year; the rate of progression is higher in patients with thyroid autoantibodies and higher thyroid stimulating hormone levels. However, thyroid function normalises spontaneously in up to 40% cases. Only a small minority of patients with subclinical hypothyroidism have symptoms, and the evidence to support that levothyroxine ameliorate the symptoms in these patients is weak.
In Ayurveda there is no direct comparison regarding Subclinical Hypothyroidism but on the basis of clinical presentation it can be correlated with Agnimandya. In Ayurved, Charak has mentioned different types of Agni and Functions of Prakrit Agni in Grahani Chikitsa Adhyaya. He also mentioned the types of Vikrit Agni and their effects in body. Under that he stated the clinical features of the Agnimandya. Various treatment in the form of Panchakarma and Kalpa i.e. oral medications are given. This study is taken to evaluate the effect of Takrarishta in the Subclinical Hypothyroidism with respect to Agnimandya.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •i) Patients having Serum TSH level between 4 to 20 mIU/L.
- •ii) Patients having Serum T3 and Serum T4 level within normal range.
- •iii) Patients who are willing to participate in study.
排除标准
- •i) Patients with MI, Stroke, Cardio Vascular surgery or major operations within 6 months prior to screening visit.
- •ii) Patients having TSH level more than 20 mIU/L or having symptoms of Myxoedema.
- •iii) Patient with previous radiation treatment of the thyroid gland.
- •v) Patient suffering from uncontrolled DM or uncontrolled Hypertension.
结局指标
主要结局
i)To decrease the serum TSH level in Subclinical Hypothyroidism after oral administration of Takrarishta for 60 days.
时间窗: 0 day ( 1st visit), 30th day ( 1st follow up) 60th day ( last follow up)
次要结局
- i)To decrease body weight and Body Mass Index in Subclinical Hypothyroidism after oral administration of Takrarishta for 60 days.(ii) To decrease clinical features (if any) in Subclinical Hypothyroidism after oral administration of Takrarishta for 60 days.)
研究者
Sunil Gunderao Solanke
PMTs Ayurved College and Eknath Ayurved Rugnalaya, Shevgaon