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临床试验/CTRI/2025/08/093038
CTRI/2025/08/093038尚未招募2/3 期

EVALUATION OF ABHAYADI GUTIKA IN MANAGEMENT OF VIBANDHA WITH SPECIAL REFERENCE TO FUNCTIONAL CONSTIPATION IN CHILDREN – A RANDOMISED CONTROLLED CLINICAL TRIAL

KLE Ayurveda Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
There might be significant effect of Abhayadi Gutika in the management of Vibandha in children with

研究概览

简要总结

Functional constipation is often described as difficult or infrequent bowel movements / deviation from normal frequency, painful defecation, the passage of hard stool and sensation of incomplete evacuation of stool

Constipation is considered as one of the most common symptom of GI system.It accounts for about 3% worldwide while in Asia this percentage lies in between 0.5% to 29.6%.Functional constipation in children lead to many gastrointestinal disorders such as appendicitis, intussusception, ulcerative colitis etc. and associated symptoms such as Abdominal pain (10-70%), Anorexia (10-25%), Incomplete evacuation(30-50%) & Psychological problems(20%). Constipation leads to fecal incontinence, painful defecation and hard stools, which are concerning problems in children as it hinders with their day-to-day life.Commonest treatment modality are Laxatives, which when given frequently leads to side effects, such as bloating , abdominal cramps or pain, nausea, vomiting, diarrhea, fluid and electrolyte changes, and can be habit forming in children. Hence there is a need for alternative modality of treatment for constipation in children. In Ayurveda various drugs have been mentioned which have Anulomana, Bhedana, deepana ,pachana karma and can have multidimensional effect to reduce the signs and symptoms of vibandh. Abhayadi Gutika is one of the drug mentioned in classics which includes karmas like Anulomana, deepana and pachana. Therefore, this study is undertaken for the management of Vibandh in children.

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
4.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex in age group between 4 years to 12 years and Patients fulfilling the diagnostic criteria and Children who are not on any medication for atleast 1 week.

排除标准

  • Children suffering from any known acute or chronic medical and surgical illness that might interfere the study for example acute GI infections or spinal cord lesions or Hirschsprung disease etc And Children with any medications that may interfere with the result like laxatives or purgatives etc will be excluded And Children on any medication or supplements causing constipation for example Iron supplements and Antidepressants and Diuretics And Children with Bleeding per rectum or mass per rectum etc that can interfere with the sudy will be excluded from the study.

结局指标

主要结局

There might be significant effect of Abhayadi Gutika in the management of Vibandha in children with

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Functional Constipation

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measured by changes in the Bristol Stool Scale and Rome IV criteria and VAS

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scale

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次要结局

  • There might be significant effect of Abhayadi Gutika in the management of Vibandha in children with(Functional Constipation measured by Ayurvedic parameters of Vibandha)

研究者

发起方
KLE Ayurveda Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Khot Akshay Manik

KLE Shri B M K ayurveda mahavidyalaya Shahapur Belgavi

研究点 (1)

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