A randomised Control Clinical Study to Evaluate the Efficay Of Kola (Badara) choorna in the Management of Vibhanda in Children
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- to assess according to Rome III criteria
研究概览
简要总结
Vibandha can be corelated to constipation. According to Ayurvedic Classic texts; Vibandha is a Sanga of Purisha caused due to vitiation of Apana Vayu in Annavaha Srotas and Purishavaha Srotas. Majority of the children report constipation due to reduced intake of fiber and water, change in dietary habits, like eating chips, biscuits or other bakery products, improper toilet training, denying natural calls in the school or changing sleep pattern. A child with functional constipation may be healthy, yet has difficulty in defecation. If they are not treated timely, then leads to complications such as gaseous distension of abdomen, hemorrhoids, fissure in ano, rectal prolapse. Kola, a type of Badara explained in Bhavaprakasha Nighantu, and Kaiyadeva Nighantuin its Shushka form shows properties like Bhedaka, Agnivardhaka, and Saraka, which is helpful in samprapti vighatana of vibandha. Hence Shushka Kola (Badara) Choorna is taken as a trail drug. Avipattikara Choorna, explained in Rasendra Chintamani, which is a proven Vibandhahara yoga is taken as a standard drug. The children fulfilling the diagnostic and inclusion criteria will be enrolled for the study and further divided into 2 groups. Where Group A will be given Avipattikara churna and Group B will be given Kola(Badara) churna respectively. The assessment will be done as per Assessment criteria. Hence this work is intended to evaluate the efficacy of Shushka Kola(Badara) Choorna in the management of Vibandha in children.
**H01–**There is no statistically significant effect of Shushka Kola (Badara) Choornain management of Vibandha in children.
H1– There is statistically significant effect of Shushka Kola (Badara) Choorna in management of Vibandha in children.
**H02–**There is neither statistically significant difference between the effect of Shushka Kola (Badara) Choorna and Avipattikara Choorna, nor Shushka Kola (Badara) Choorna is better than Avipattikara Choorna in management of Vibandha in children.
H2– There is statistically significant difference between the effect of Shushka Kola (Badara) Choornaand Avipattikara Choorna with Shushka Kola (Badara) Choornashowingbetter effectthan Avipattikara Choorna in management of Vibandha in children.
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
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •The children of either gender between the age group of 6-12 years.
- •Children fulfilling the ROME III criteria
- •Children presenting with symptoms, since 2 months.
- •(as per ROME III criteria)
- •Whose parents are willing to give consent, will be registered for the clinical study.
排除标准
- •Children having constipation secondary to any of the other disease like hypothyroidism, hirschprung’s disease.
- •Presenting with any structural anomalies of anal canal.
结局指标
主要结局
to assess according to Rome III criteria
时间窗: 0th, 4th, 7th, 16, 22nd Day
A. Painful defecation (Assessed by VAS)
时间窗: 0th, 4th, 7th, 16, 22nd Day
B. Frequency of defecation
时间窗: 0th, 4th, 7th, 16, 22nd Day
C. Number of episodes of fecal incontinence
时间窗: 0th, 4th, 7th, 16, 22nd Day
D. Excessive stool retention
时间窗: 0th, 4th, 7th, 16, 22nd Day
E. Hard bowel movement
时间窗: 0th, 4th, 7th, 16, 22nd Day
F. Large fecal mass in the rectum
时间窗: 0th, 4th, 7th, 16, 22nd Day
G. History of large diameter stools that may obstruct the toilet
时间窗: 0th, 4th, 7th, 16, 22nd Day
次要结局
- to assess Kshutmandya (reduced appetite), Udarashoola (Abdominal pain), Vilomascha Maruta (upward movement of flatus in the abdomen)(0th, 4th, 7th, 16, 22nd Day)
研究者
Dr Ghuge Avinash Laxman
Alvas Ayurveda medical college and hospital
