An open label Randomized placebo controlled clinical trial on Saindhavadi Yoga in the management of Vibandha W.S.R. to Functional Constipation in Children.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To improve the quality of life in Children suffering from functional constipation.
研究概览
简要总结
Functional constipation is one of the lifestyle disorders.To improve the quality of life suffering from functional constipation therefore I selected this clinical trial. Clinical trial will be done on Saindhavadi yoga . Maximum 60 Functional constipation diagnosed children aged 3-12 yr clinical studies into two group of treatment modules. Each segment of the treatment module will be of 2 months after each treatment there is a gap of 15 days .Total duration of trial is 75 days. Follow up will be performed before intervention and after 15 days of each treatment module . A follow up will be done after 15 days of complete clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children fulfilling ROME IV Criteria.
- •Most include 2 or more following occurring at least once a week.
- •for a minimum 1 month with insufficient criteria to diagnose irritable bowel syndrome.
- •Two or fewer defecations in the toilets per week in a child of a developmental age of at least 4 year
- •At least one of fecal incontinence per week.
- •History of retentive posturing or excessive volitional stool retention.
- •History of painful or hard bowel movement.
- •Presence of a large fecal mass in the rectum.
- •History of large diameter stool that can obstruct the toilets after appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
排除标准
- •Children with organic disorders as Hischsprung disease should be excluded.
- •Children Suffering from liver disorders should be excluded.
- •Children suffered with other systemic illness like T.B. HIV should be excluded.
- •Drug induced constipation should be excluded (drugs such as opiates, anticholinergic agents, phenobarbitone, vincristine and lead).
- •5.Children not fulfilling the criteria of Rome IV.
结局指标
主要结局
To improve the quality of life in Children suffering from functional constipation.
时间窗: At 75th day of completing clinical trial.
次要结局
- To assess the efficacy of saidhavadi yoga.(1st day, 15th day, 30th day, 45th day, 60th day, 75th day)
研究者
Vanshika Dhama
state ayurvedic college and hospital Lucknow