CTRI/2024/11/076307尚未招募2 期
Study Of Efficacy Of Vidangadi Lauha With Madhu As An Add On Effect In The Management Of Hypothyroidism With Obesity
Shriya Vidhyadhar Kale1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月9日最近更新:
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
- 1.To assess the role of Vidangadi Lauha with madhu on symptoms of Hypothyroidism.
研究概览
简要总结
This study is randomised, controlled, clinical trial of add on effect of Vidangadi Lauha tablet 250mg BD with madhu after food for 45 days in the Management of Hypothyroidism with Obesity. Follow up will be taken on 0th, 23rd and 46th day.
This study is conducted as PG Course at single centre. The primary outcome is to assess the role of Vidangadi Lauha with madhu on symptoms of Hypothyroidism and to assess the Medohar property of Vidangadi Lauha with madhu (by changes in BMI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having clinical features of Hypothyroidism.
- •2.Patients willing to give their consent and participate in the study.
- •3.Serum TSH level above 4.25mlU/mL.
- •4.BMI more than or equal to 25 Kg per meter square.
- •5.Age 18-45 years of either sex.
- •6.K/C/O Hypothyroidism from less than 10 years.
- •(Anti- Thyroid medications started from at least 3 month before commencement of treatment.).
排除标准
- •1.Patients suffering from Secondary Hypothyroidism, Hashimato Thyroiditis.
- •2.Pregnancy, lactating mothers.
- •3.patients having associated diseases like ischemic heart diseases, uncontrolled hypertension, uncontrolled diabetes, myocardial infarction, cerebrovascular events, Cardiac arrhythmias, malignancy and suffering from Psychosis.
结局指标
主要结局
1.To assess the role of Vidangadi Lauha with madhu on symptoms of Hypothyroidism.
时间窗: 6 weeks
2.To assess the Medohar property of Vidangadi Lauha with madhu (by changes in BMI)
时间窗: 6 weeks
次要结局
- To assess the role of Vidangadi Lauha with madhu in Thyroid stimulating activity (by changes in serum TSH level.)(45 days)
研究者
Shriya Vidhyadhar Kale
Government Ayurvedic College Nanded
研究点 (1)
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