跳至主要内容
临床试验/CTRI/2025/06/088051
CTRI/2025/06/088051尚未招募2/3 期

Randomized controlled clinical study to evaluate the efficacy of Shuntyadi Yoga in Vibandha with special reference to constipation in children.

Dr Bharat Ganesh Subhashrao1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月15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
30
试验地点
1
主要终点
Significant decrease in ‘Vibandha’ ( Constipation ) based on Constipation Assessmnet Criteria and Bristol stool scale.

研究概览

简要总结

Nurturing today’s children is essential for a brighter future, as they symbolize tomorrow’s potential. The physical wellbeing of young children has a direct effect on their overall development. Regular defecation is one of the indicators of good health. The normal defecation pattern of children might change according to age and dietary habits. Changes in defecation pattern may cause some physical and psychological problems. Thus, understanding the individual age-related normal and abnormal defecation patterns is considerably important. Understanding Constipation/Vibandha, i.e. infrequent defecation, painful defecation, or both, will help in understanding the overall health of the child.

The prevalence of childhood constipation in general population varies widely ranging from 0.7% to 29.6%. It accounts for 3% of visits to general Pediatric clinics and accounts for about 25-30% of visits to pediatric gastroenterologists.

Constipation is gastro intestinal disease, defined as infrequent defecation, painful defecation, or both. Initial painful defecation leads to voluntary withholding which further paves way for prolonged stasis of fecal matter, as a result of this there is increase in its size and consistency thus a vicious cycle is initiated with more pain on defecation and constipation.

This leads to distress for the child further causing recurrent discomfort in abdomen, reduced appetite also exhibits changes in behavior, such as mood swings and lack of interest in studies or difficulty in concentrating. Constipation is often negatively perceived by peers and possess a significant burden on both the child and parents. So, it is important that the disease is treated at the beginning stage itself before it leads to further complications like painful defecation with partial evacuation and Fissure in Ano.

Vibandha can be described as Mala Apravrutti due to solidification of Purisha caused by Dushti of Apana Vayu, Annavaha and Purishwaha Srotas. It is seen as one of the symptoms of Udavarta, Anaha, Adhmana and Arsha. In Vibandha there is Purisha Vega Dharana which has the potential to manifest systemic complications such as Pindikodveshta (Calf muscles cramps), Pratishyaya (Coryza), Shiroruja (Headache), Parikartika (Anal fissures), Agnivadha (Loss of digestion capacity) Vatamutra Sanga (Obstruction of urine and flatus) and Hrudgada (Diseases of the heart). Thus, early diagnosis and management of Vibandha is essential for Swasthya of a growing child.

Main line of treatment according to modern science is considered to be use of laxatives and enema which might temporarily relieve the condition and might reoccur later for the prevention of recurrence long term laxative maintenance is required. Most common side effects of laxatives are excessive gassiness, bloatedness and crampy abdominal pains. Long term use has adverse effects as overstretched or lazy colon which can result in Irritable Bowel Syndrome. The body’s nutrient balance is also negatively impacted by causing a disturbance in mineral balance like magnesium, sodium, potassium, and phosphates, which hamper child’s normal growth and development.

The treatment principles adapted in Ayurveda are Deepana (Increase the digestive fire), Pachana (Process of Digesting Food), Vata-anulomana (downward movement of Vata) and Rechana (Purgation). There is an impetus to explore the drugs having capacity to cure Vibandha without side effects and recurrence. One such formulation is Shuntyadi yoga mentioned in Bhavaprakasha which is administered with Sahapana of Guda (jaggery). It has main stay on Amajirna, Arsha and Malavibandha by the virtue of its properties. This Yoga is easily acceptable and palatable by children to relieve and prevent Vibandha. Thus, this study is an attempt to evaluate the efficacy of Shuntyadi Yoga on 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
2.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Children in between the age group of 2 to 6 years irrespective of religion, gender, and socio-economic status will be included.
  • Children having clinical features of constipation for less than or equal to 2 weeks.
  • Children whose parents are willing to sign the written consent form and to follow the protocol.

排除标准

  • Children with anatomical malformations of anal canal.
  • e.g. Anal stenosis, Hirschsprung’s disease, etc.
  • Children who are known case of Inflammatory bowel disease, Irritable Bowel Syndrome, Neuromuscular disease.
  • Children under drugs that induce constipation or any other long-term medication, e.g. Opioid pain relievers, Anti-cholinergic agents, Antispasmodics, etc.

结局指标

主要结局

Significant decrease in ‘Vibandha’ ( Constipation ) based on Constipation Assessmnet Criteria and Bristol stool scale.

时间窗: 0th, 15th day, 30th day

次要结局

  • 1. Generation of in - depth analysed data on the different aspect of the disease.(2. Generation of data on possible unexpected drug reaction.)

研究者

发起方
Dr Bharat Ganesh Subhashrao
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Dr Bharat Ganesh Subhashrao

Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore

研究点 (1)

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