Efficacy of Agnimukha Churna and Hamsapadadi Vati in the Managememt of Subclinical Hypothyroidism-an open labelled randomized standard controlled clinical trail
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the serum TSH level
研究概览
简要总结
The trial is a randomized standard controlled clinical trial to evaluate the role of Agnimikha churna and hamsapadadi vati in the management of Subclinical Hypothyroidism. A total of 30 patients will be enrolled in the study. Selected patients will be divided into 2 groups based on computer-generated randomization. In one group Agnimukha churna 6gm, twice a day will be given before lunch and dinner with lukewarm water. Hamsapadadi Vati 500mg 2 vati will be given after lunch and dinner for 60 days. In the second group levothyroxine tablet 1.6mcg/kg of body weight will be given empty stomach in the morning for 60 days. Followups will be carried out weekly for 1-month duration. The primary outcome of the study is a reduction in serum TSH levels.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18-60 years of either gender.
- •Newly diagnosed or previously diagnosed patient of TSH level 4.32-10mlU/L.
- •Patients having no symptoms or few symptoms of subclinical hypothyroidism like tiredness, weakness, dry skin, cold intolerance, hair loss, constipation, weight gain with poor appetite, and menstrual abnormalities.
- •Patients willing to participate in the study.
排除标准
- •Serum TSH level more than 10mIU/L and less than 4.32mIU/L 2)Patient taking allopathic medication for subclinical hypothyroidism.
- •Patients suffering from any other systemic illness viz.
- •with a known case of uncontrolled Diabetes (Random blood sugar more than 200mg/dl), uncontrolled Hypertension (systolic blood pressure more than 140mmHg or diastolic blood pressure more than 90 mmHg), Psychiatric disorders, cardiovascular events, cerebrovascular event, malignancy.
- •Patients suffering from secondary hypothyroidism, Hashimoto’s thyroiditis.
- •Pregnant and lactating patients.
- •Patients aged below 18 years and above 60 years of either sex.
结局指标
主要结局
Reduction in the serum TSH level
时间窗: 60 days
次要结局
- a) Improvement in symptoms of subclinical hypothyroidism.(b) Improvement in Agni)
研究者
Dr Sushmita Ninganure
Institute of Teaching and Research in Ayurveda, Jmanagar