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临床试验/CTRI/2025/05/086930
CTRI/2025/05/086930尚未招募3 期

A Comparative Clinical Study To Evaluate The Effect Of Shatahvadi Niruha Basti Over Pippalyadi Taila Matrabasti In The Management Of Vibandha(Funtional Constipation) In Children.

Dr Kallagodi Lakshmidevi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月7日最近更新:
适应症

试验速览

阶段
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
Shatahvadi niruha basti has superior effect over Pippalyadi taila matrabasti in the management of Vibandha (functional constipation)

研究概览

简要总结

Functional constipation is characterized by infrequent bowel movements, hard and/or large stools, painful defecation and fecal incontinence and is often accompanied by abdominal pain. It is one of the lifestyle disorders caused due to the suppression of urges and irregular eating habits. The prevalence of childhood constipation in general population varies widely ranging from 0.7% to 29.6% and a mean female to male ratio of 2.1:11. It accounts for 3% of visits to general paediatric clinics and accounts for up-to 25% of visits to paediatric gastroenterologist.  It is commonly seen among toddlers and pre-school children2 and it is more frequent when fibre dietary food and liquid diet intake are restricted.

Though functional constipation is a gastro-intestinal disease, it also have the impact on the general health of a child, if not treated at the right time, it may lead to distress for the child further leading to recurrent discomfort in abdomen, reduced appetite, and the child even fears to defecate due to the pain experienced while passing hard stools. So, it is important that the disease is treated at the beginning stage itself before it leads to further complications like fissures, rectal prolapse and haemorrhoids.

Main line of treatment according to modern science is considered to be use of laxatives like Polyethylene glycol, Lactulose, Magnesium Hydroxide etc and enemas like Bisacodyl, Sodium docustate which might temporarily relieve the condition and might reoccur later.

Vibandha is one of the Vataja nanatmaja vikara mentioned in ayurveda which is analogous to Constipation.  It is caused due to Dusti of Apanavayu, Annavaha and Purishavaha srotas dusti. Apanavayu is one among the 5 types of Vata and the function of Apanavayu is Nishkramana of mala, mutra, shukra, arthava and garbha. Vibandha is frequently mentioned in ayurveda but no dedicated chapter is available for the same. It is mentioned as a Nidana, Poorvaroopa, Roopa, Upadrava and as a Panchakarma vyapad in various contexts in the classical texts and is seen as one of the symptoms in udavartha, anaha, adhmana, arsha.

So far few researches have been done on constipation in children by administering internal medications like Haritaki, Trivruthadi avalehya, shuntyadi syrup etc. but there is a chance of getting acquainted to internal medications over the period of time. Hence, it is difficult to manage the condition alone with oral medications.

For Vata vyadhi, Basti is one of the treatment mentioned in ayurveda and it is said as ardha chikitsa. But, basti is not been used frequently and not a single study on shodhana basti is available in existing data. Hence, Shodhana basti has been taken for present study. As alone Snehabasti can also relieve the condition but it may not do shodhana, hence Shodhana basti is selected here for the present study.

Shatahvadi niruha basti mentioned in Kashyapa Samhita consist of Shatahva, Pippali, Kusta, Vacha, Devadaru, Poothika, Harenu, Bilva and Madanaphala and is said to relieve conditions like shoola, anaha and Vibandha. Hence present study has been taken to evaluate the effect of Shatahvadi niruha basti over Pippalyadi taila matrabasti in the management of Vibandha.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
1.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • •1.The children of either gender between the age group of 1-10 years fulfilling the diagnostic criteria of Vibandha.
  • •Children whose parents are willing to participate them in the study by giving informed parent consent.

排除标准

  • •Children with organic causes like Hirschsprung’s disease, inflammatory bowel disease, anatomical malformations of anal canal and hypothyroidism are excluded from the study.

结局指标

主要结局

Shatahvadi niruha basti has superior effect over Pippalyadi taila matrabasti in the management of Vibandha (functional constipation)

时间窗: 28 days

次要结局

  • Increased appetite(28 Days)

研究者

发起方
Dr Kallagodi Lakshmidevi
申办方类型
Other [Self ]

研究点 (1)

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