The effect of mud pack to the abdomen on gastric motility in patients with dyspepsia - A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gastric myoelectrical activity will be measured by using an electrogastrogram (MP160 BIOPAC system manufactured in the United States) on the 1st and 14th day of intervention. On Day 1, Pre, post and follow-up assessments will be taken before, immediately after and 30 minutes after the intervention to find the immediate effect. On day 14 post assessments will be performed to find the short-term effect.
研究概览
简要总结
A randomized controlled trial will be adopted for this study. 100 participants will be recruited from Government yoga and naturopathy medical college and hospital and will be randomized into two groups of 50 in each group namely study and control group. After basline asssessment of outcome variables, both the groups will undergo their respective interventions, and assessments will be taken immediately after the intervention and 20 minutes after 150 ml of water load. After 14 days, post assessment will be taken immediately after the intervention and 20 minutes after the 150 ml of water load. The study group will receive mud pack to abdomen and the control group will be advised to take supine rest for 20 minutes. The primary outcome variables will be gastric myoelectrical activity measured using electrogastrogram. The secondary outcome variable will be dyspepsia symptom diary. The values are collected basline, immediately after the 1st intervention, and 20 minutes after the 150 ml of water load, After 14 days of intervention, asessment will be taken immediately after the intervention and 20 minutes after the 150 ml of water load. It will be analysed using appropritae statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 to 60 years 2) Both gender (male and female) 3) Participants who are willing to give their consent 4) Participants with dyspeptic symptom of not less than 3months.
排除标准
- •Patients already on drugs affecting Gastrointestinal motility, like prokinetics, and antipsychotics.
- •Patients with a past history of abdominal surgery.
- •Mental illness 4) Women during menstruation and pregnancy.
结局指标
主要结局
Gastric myoelectrical activity will be measured by using an electrogastrogram (MP160 BIOPAC system manufactured in the United States) on the 1st and 14th day of intervention. On Day 1, Pre, post and follow-up assessments will be taken before, immediately after and 30 minutes after the intervention to find the immediate effect. On day 14 post assessments will be performed to find the short-term effect.
时间窗: Assessments will be conducted on Day 1 before the intervention and 20 minutes after it, following the intake of 150 ml of water. A post-assessment will then be carried out 20 minutes after the water load. On Day 14, a post-assessment will be conducted 20 minutes after the intervention and water load.
次要结局
- Functional dyspepsia symptom diary(Assessments will be taken on day 1 and day 14.)
研究者
Arunthathi .R
Government yoga and naturopathy medical college and hospital