A clinical study on the management of primary hypothyroidism with a unani polyherbal formulation-An open label single arm study.
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, Free T3 & T4
研究概览
简要总结
Diagnosed cases of Primary Hypothyroidism, whofulfill the inclusion criteria, will be enrolled in the trial after making themunderstand about the study & taking their informed written consent.Patients will be given the test drug, prepared in the extract formof Unani Polyherbal formulation, 2 capsules (500 mg each) twice a day orallyand would be followed up on 10th,20th, 30thand 42nd day and will be clinically evaluated on assessment parameters. The data will be statistically analyzed using appropriatestatistical tests. The safety of the test drug will be ensured bymonitoring the Hemogram and biochemical indicators for kidney and liverfunctions. Any adverse effects of the drug during study will be noticedcarefully.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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 Primary Hypothyroidism with TSH level >20mIU/L.
- •Patient willing to participate and sign the consent form.
- •Patient willing to discontinue the drugs taking for the treatment of Primary Hypothyroidism.
排除标准
- •Patient unwilling to sign the consent form.
- •Patient taking hormonal therapy.
- •Pregnant and lactating women.
- •Renal and hepatic insufficiency and malignancy.
- •Patient with tachyarrhythmia.
- •Patient with increased bowel movements.
- •Patient with menorrhagia, metrorrhagia and polymenorrhea.
- •Patient with parkinsonism and tremors.
结局指标
主要结局
TSH, Free T3 & T4
时间窗: 6 Week
Tiredness
时间窗: 6 Week
Loss of appetite
时间窗: 6 Week
Cold intolerance
时间窗: 6 Week
Constipation
时间窗: 6 Week
Sleep
时间窗: 6 Week
will be assessed.
时间窗: 6 Week
次要结局
- Lipid Profile and Quality of Life will be assessed(6 Week)