A randomized controlled clinical study to evaluate the efficacy of Dhatryadi Syrup in the management of Malavibandha in the preschool children (3 to 6 years).
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Dhatryadi Syrup in the managment of Malavibandha for 7 days.
研究概览
简要总结
Malavibandha is not a disease, it’s a symptom. But this symptom has become a major issue in today’s life. According to the Ayurvedic Shabda Kosh, Vibandha means Apravrutti. Hence, Malavibandha can be defined as Mala Apravrutti. MalaVibandha can be correlated with Constipation with its clinical manifestations. Constipation is defined as delay or difficulty in defecation due to hardened faeces present for 2 or more weeks and sufficient to cause significant distress to the patient
Vibandha is due to altered food habits, raised fast food culture, changing sleep patterns. improper toilet training, lack of exercise and impact of stressful child. In Mala Vibandh, Anulom Gati of Apan Vayu is obstructed and becomes Pratilom. Therefore, Purish is obstructed in Pakvashaya and further compliactaions such as unsatisfactory bowel emptying, indigestion of food, etc. occurs which leads to deterioration of the health of the child.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of preschool age group will be selected irrespective of gender, caste and religion with following criteria-
- •Children fulfilling ROME IV Criteria (must include at least 2 of the following symptoms) two or fewer defecations per week at least 1 episode of faecal incontinence per week History of retentive posturing or excessive violent stool retention History of painful or hard bowel movements Presence of large faecal mass in the rectunm History of large diameter stools that can obstruct the toilet
- •Abdominal Pain 3.
排除标准
- •K/C/O Other systemic illness like abdominal Kochs K/C/O Hormonal disease as Hypothyroidism K/C/O Disorders as Hirschsprungs disease Children with severe abdominal pain.
结局指标
主要结局
To assess the efficacy of Dhatryadi Syrup in the managment of Malavibandha for 7 days.
时间窗: 7 days where follow up will be on 3rd and 7th day
次要结局
- To observe the adverse effects of Dhatryadi Syrup in the management of Malavibandha if any.(7 days where follow up will be on 3rd and 7th day)
研究者
Dr Aditi Avinash Khadamkar
PDEAs College of Ayurved and Research Centre