跳至主要内容
临床试验/CTRI/2025/06/089608
CTRI/2025/06/089608尚未招募3 期

Randomised comparative clinical study to evaluate the efficacy of Mustadi Yapana Yoga Basti followed by Ashwattha Ksheerapaka and Bimbi Moola Ksheerapaka orally in Shayyamutra with special reference to Nocturnal Enuresis in children.

Dr Bhaik Rahul Bajirao1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Significant decrease in frequency and occurrence of Shayyamutra with special referance to Nocturnal enuresis assessed based on NICE Clinical guidelines.

研究概览

简要总结

Nocturnal Enuresis (NE), or bed-wetting, is a psychosomatic disorder that significantly affects the physical and emotional well-being of children, particularly beyond the age of five. It is prevalent in 10–15% of children aged 5–10 years and about 5% in those aged 10–15 years, with a higher incidence in boys. Children with Nocturnal Enuresis often suffer from low self-esteem, social withdrawal, and academic decline. Though often seen as behavioral,Nocturnal Enuresis is increasingly recognized as a developmental delay in achieving nighttime bladder control. While bladder overactivity is a primary cause, conventional treatments like bed alarms and Desmopressin have limitations in compliance and long-term efficacy. In Ayurveda, Nocturnal Enuresis corresponds to Shayyamutra, understood as Anyonya Avrita Vata and Tamo-Kapha Avarana of Hridaya, manifesting as Apana Avrita Vyana Vayu. Management includes Pakvashaya Shodhana with Yapana Basti and Grahi Chikitsa with Mootrasangrahaneeya Dravyas. Previous studies lack a holistic approach. This study aims to address Shayyamutra comprehensively through Mustadi Yapana Yoga Basti and oral administration of Ashwattha and Bimbi Moola Ksheerapaka, which offer Balya, Brimhana, and Mootrasangrahaneeya effects.

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

  • Subjects diagnosed with Nocturnal enuresis between the age group of 6-12 years irrespective of their religion, gender and socio-economic status will be included.
  • Subjects with history of Nocturnal enuresis twice a week for at least 3 consecutive months.
  • Subjects with both persistent and regressive type of Nocturnal enuresis
  • Subject whose parents are willing to sign written consent form and follow the protocol.
  • Subjects whose urine routine is normal.

排除标准

  • Subjects with Diurnal enuresis.
  • • Subjects who are known case of Spina Bifida, Vesico-Urethral reflux, Neurogenic Bladder etc.
  • • Subjects who are known case of Neuro Muscular Developmental delay like Cerebral palsy, Mental retardation, etc.
  • • Subjects who are known case of epilepsy and under anti-epileptic drugs.
  • • Subjects who are known case of Urinary Tract Infection and other renal Disorders.

结局指标

主要结局

Significant decrease in frequency and occurrence of Shayyamutra with special referance to Nocturnal enuresis assessed based on NICE Clinical guidelines.

时间窗: 0th, 8th, 30th, 60th day

次要结局

  • •To understand the Nidana Panchaka of Shayyamutra with special reference to Nocturnal enuresis in children.(•To monitor the adverse drug reaction.)

研究者

发起方
Dr Bhaik Rahul Bajirao
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Bhaik Rahul Bajirao

Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka -560082

研究点 (1)

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