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临床试验/CTRI/2026/04/108648
CTRI/2026/04/108648尚未招募不适用

A Randomized Comparative Clinical trial to evaluate the efficacy of Aragwadha Kapila Avaleha and Haritaki Pippali Avaleha in the management of childhood constipation among pre school children aged 3 to 6 years.

PDEAs college of ayurveda and research centre1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年4月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
33
试验地点
1

研究概览

简要总结

Childhood constipation is a common pediatric disorder affecting bowel habits and quality of life in preschool children. The majority of cases are functional in nature. In Ayurveda, childhood constipation can be correlated with Malavibandha, which occurs due to vitiation of Vata dosha and impaired Apana Vayu function leading to difficulty in defecation and hard stools.

The present study is a randomized comparative clinical trial designed to evaluate and compare the efficacy of Aragwadha Kapila Avaleha and Haritaki Pippali Avaleha in the management of Malavibandha (functional constipation) in preschool children aged 3–6 years. A total of 66 children fulfilling Rome IV criteria for functional constipation will be randomly allocated into two groups. Group A will receive Aragwadha Kapila Avaleha and Group B will receive Haritaki Pippali Avaleha for a duration of 14 days.

The outcome will be assessed based on improvement in stool frequency, stool consistency, painful defecation, and associated symptoms such as abdominal pain and anorexia. The study aims to provide scientific evidence for the efficacy and safety of these Ayurvedic formulations in the management of childhood constipation.

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

  • Diagnosed with functional constipation as per standard clinical or ROME IV CRITERIA 2) Straining during more than 25% of defecations.
  • Lumpy or hard stools (Bristol stool Scale 1-2) more than 25% defecations.
  • Sensation of incomplete evacuation more than 25% defecations.
  • Presence of a large fecal mass in the colon 6) History of large diameter stools which may obstruct the toilet.
  • Associated symptoms- Abdominal pain, Anorexia.

排除标准

  • 1.Constipation due to organic or structural causes.
  • Hirschsprug’s disease, piles. 2.Known case of cerebral palsy or constipation due to any other neuromuscular disorder.
  • Known case of hypothyroidism, Irritable Bowel Syndrome. 4.Children with severe abdominal pain. 5.Children with known case of any food allergy.

研究者

发起方
PDEAs college of ayurveda and research centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Karishma Shukla

PDEAs College of Ayurveda and Research Centre Nigdi, Pune

研究点 (1)

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