A Clinical Study On Subclinical Hypothyroidism and its Management with An Extract of Jawarish e Bisbasa Formulation- A Randomized Double-Blind Placebo Controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- TSH, cold intolerance, tiredness, constipation will be assessed
研究概览
简要总结
Diagnosed cases of subclinical hypothyroidism who fulfill the inclusion criteria, will be enrolled in the study after making them understand about the study and taking their informed written consent. Patients will be allocated into two groups, 20 in test group & in control group respectively by using "block randomization" method. Test group will be subjected to 1 capsule (500 mg each) of extract of jawarish e bisbasa formulation twice a day orally. Blinding would be done by the pharmacist and distribution of drug will be as per the block randomization method. Patients would be followed up on 7th, 15th, 30th and 42nd day and clinically evaluated on assessment parameters. The data for both the groups will be statistically analyzed and compared with each other using appropriate statistical tests. The safety of the test drug will be ensured by monitoring the Haemogram with ESR and serological indicators for kidney and liver. Any unwanted effect of the drug during study will be noticed carefully.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed cases of subclinical hypothyroidism, patients willing to participate and sign the understood and informed consent form.
排除标准
- •Pregnant and lactating women, renal and hepatic sufficiency, malignancy, patient unwilling to sign the informed consent form, patient taking hormonal therapy.
结局指标
主要结局
TSH, cold intolerance, tiredness, constipation will be assessed
时间窗: 6 weeks
次要结局
- To assess lipid profile(6 weeks)
