Effects of three month of yoga therapy on autonomic functions, oxidative stress ,Inflammatory markers in hypothyroid patients on thyroid supplement, A cross sectional, analytical, randomized open label study in a tertiary care centre ,in South India.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- expected difference in mean of total power of heart rate variablity is 3.4
研究概览
简要总结
This study is an interventional study which studies effect of yoga therapy on hypothyroid patients in addition to thyroid supplementation. From rural and urban population from Puducherry and nearby districts of Tamilnadu ,the participants attending Endocrinology OPD in JIPMER will be screened and a detailed history will be obtained. After meeting the inclusion and exclusion criteria, the participants will be divided into two groups ( Intervention group and Control group) based on computer generated sequence .5 ml of fasting blood sample will be collected for biochemical analysis, following which breakfast will be provided to them. After breakfast , heart rate variability and baroreceptor sensitivity will be recorded.Then yoga therapy will be given in ACYTER (Advanced Center of Yoga Therapy and Educational Research) as per the protocol, three times in a week for Intervention group. The participants in the Yoga group are advised to practise Yoga for a period of three months. After three months ,the primary outcome heart rate variability and baroreceptor sensitivity and secondary outcomes like TNF- alpha, IL-6 ,total oxidant and antioxidant level will be taken in both groups and will be compared.
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Hypothyroid patients of both genders belonging to age group of 18 to 50 with TSH value below 10 units will be included in study.
排除标准
- •Diabetes Mellitus, Hypertension, Heart disease, Autonomic Dysfunction Those taking Chronic Drugs that can influence autonomic function, Those doing Yoga Practice.
结局指标
主要结局
expected difference in mean of total power of heart rate variablity is 3.4
时间窗: Improvement in total power of heart rate variablity in hypothyroid patients undergoing yoga therapy at end of three month (12 weeks ) from baseline recording
次要结局
- improvises the thyroid profile,lipid profile, antioxidant level and lowers the oxidative stress and inflammatory markers like IL-6,TNF -Alpha in hypothyroid patients undergoing yoga therapy.(Three months of yoga therapy reduces the inflammatory markers and oxidative stress.)