A clinical study on Combined effectiveness of Yoga Module and Chitrakadi vati in Hypothyroidism
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement in clinical features of Hypothyroidism like, reduced TSH level, weight gain etc
研究概览
简要总结
Diagnosed cases of 120 subjects fulfilling inclusion criteria will be selected for the study after subjecting them through clinical and lab examination as per the proforma prepared for the study irrespective of gender, age, and religion and made in to 3 groups
Group A - Minimum of 40 diagnosed cases of Hypothyroidism will be selected and explained nature of study and taken written consent and adviced Yoga Module for 50min with each Asana 5 cycles for period of 90 days.
Group B - Minimum of 40 diagnosed cases of Hypothyroidism will be selected and explained regarding Nature of Study and taken written consent and administered Chitrakadi vati 250mg BD with potable water before meal for 90 days.
Group C- Minimum of 40 diagnosed cases of Hypothyroidism will be selected and explained regarding Nature of Study and taken written consent and adviced Yoga Module for 50 min with each asana 5 cycles along with Chitrakadi vati of 250mg BD administered for 90 days.
Medicines will be procured from SDM pharmacy college Udupi and designed Yoga protocol will be adviced and demonstrated and study will be conducted for period of 90 days.
Data will be collected and tabulated ,analysed using SPSS version 20 or using appropriate Statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with TSH value between 5 -30 mUI /L 2.Subjects fulfilling the diagnostic criteria 3.Subjects who are freshly diagnosed as Hypothyroidism.
- •4.Known case of Hypothyroidism with or without medication 5.Subjects between the age of 20 to 60 years of either gender.
- •6.Subjects fit for regular practice of yogasana 7.Subjects who are ready to sign informed consent form.
排除标准
- •1.Primary Hypothyroidism with elevated TSH & low serum thyroxine (T4) and triodothyronine (T3) (Hashimoto thyroiditis) & Post Radio Iodine Therapy Hypothyroidism&Post-operative Hypothyroidism.
- •2.Known subjects of Thyrotoxicosis, Congenital Anamolies, Myxedema, Secondary Hypothyroidism and its complications.
- •3.Subjects established withCardiac disorders, Hyper tension,Diabetes mellitus and Hyper acidity.
- •4.Hypothyroidism in pregnancy and lactating mother.
- •5.Known case ofNeoplasia, Toxic Goitre.
- •6.Known case of mental illness.
- •7.Any condition which investigator thinks may jeopardize the study.
结局指标
主要结局
Improvement in clinical features of Hypothyroidism like, reduced TSH level, weight gain etc
时间窗: 03 months
次要结局
- improvement in associated complaints like hairfall, Menustral disorders.(03months)