Effect of nutritional counselling program on nutritional indicators, Quality of life and side effects associated with anti-tubercular treatment among patients with pulmonary tuberculosis: A Randomised controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To observe how health education combined with dietary guidance affects nutritional indicators, quality of life and prevention of side effects associated with Anti-tubercular treatment among patients with pulmonary tuberculosis (PTB)
研究概览
简要总结
Pulmonary tuberculosis (PTB) is one of the most common communicable diseases among top ten causes of death worldwide. Tuberculosis is a contagious, infectious disease caused by the bacteria Mycobacterium tuberculosis.[1] PTB is more frequent in immunocompromised and weak individuals, and symptoms include dyspnoea, cough, and afternoon hypothermia.
Undernutrition is one of the major causes of Malnutrition among the patients who are taking Anti-tubercular drugs. However, the studies highlighted the need for evidence concerning the effect of nutritional supplementation on patients on anti-tubercular drugs. As per WHO, 2013 guideline on nutritional care and support for patients with tuberculosis, has recommended the provision of nutritional food as part of a package to improve TB treatment adherence. This further highlighted the strong recommendation of Nutritional assessment and counselling along with management of undernutrition and severe acute malnutrition. Viewing this, we researchers felt a need to do this study on nutritional counselling.
The aim of this study is to observe how health education combined with dietary guidance affects nutritional indicators, quality of life and prevention of side effects associated with Anti-tubercular treatment among patients with pulmonary tuberculosis (PTB), in order to provide a theoretical foundation for improving PTB patients; compliance and treatment outcomes.
Health education combined with dietary guidance for patients with pulmonary tuberculosis can deepen patients’ understanding of disease and nutritional knowledge, improve treatment compliance, improve their nutritional status, enhance their immune function, accelerate sputum bacterial conversion, enhance treatment effect, and improve their quality of life. So we are expecting to get a similar outcome with the help of the nutritional counselling program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 to 65 years.
- •Patients who will be available during the time of data collection.
- •Patients who will be willing to give consent to participate in the study.
- •Patients who can understand Hindi or English.
- •Microbiological confirmed diagnosis of Patients with pulmonary tuberculosis within one month and who are taking ATT.
排除标准
- •Patients who have severe anaemia.
- •Patients who have severe impairment of major organ function.
- •The patient has cognitive impairment.
- •Patients who are pregnant or lactating.
结局指标
主要结局
To observe how health education combined with dietary guidance affects nutritional indicators, quality of life and prevention of side effects associated with Anti-tubercular treatment among patients with pulmonary tuberculosis (PTB)
时间窗: 1 year
次要结局
- Frequency of Sideeffects of Anti-tubercular treatment(at 6 months, 1 year)
研究者
Nipin Kalal
AIIMS Jodhpur