Randomized Controlled Trial to evaluate the efficacy of Draksha syrup in Vibandha in children ( 2-6 years) with reference to Functional Constipation.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- DRAKSHA SYRUP is effective in Vibhandha in children within 7 days
研究概览
简要总结
Sushrutacharya while explaining the digestive system of our body cited that the process of digestion occurs over time, drawing downward (the waste products), assisted by the wind (air or vata). It governs the excretion of feces, urine, semen, menstrual blood, and other substances. When aggravated, it causes severe diseases related to the bladder, rectum, and other associated areas. In Ayurveda, constipation is known as Vibandha or Badhapurish, presenting as a common issue in childhood that often causes considerable parental concern. It is characterized by difficulty in passing stools, typically associated with dry and hard stools and infrequent bowel movements, most prevalent among children aged 2 to 6 years. The causes of Vibandha in Ayurvedic perspective include factors like breastfeeding from a mother with vitiated Vata (Vata Dushita Stanya Sevana), parasitic infections (Krimi), and suppression of natural urges (Parish Vega-Vidharana), which disrupt normal digestive functions1. These disturbances lead to the accumulation of Ama (undigested or improperly digested food substances), aggravation of the Vata dosha (responsible for movement), and weakening of digestive fire (Jatharagni Mandya), culminating in the manifestation of constipation.2 If left untreated, Vibandha can result in complications such as vomiting (Chardana), depletion of bodily fluids (Rasa Kshaya), and emaciation (Karshya). Prevention strategies focus on dietary adjustments, including a high-fiber diet and adequate fluid intake, alongside promoting regular physical activity and timely bowel habits. Treatment of Vibandha involves a holistic approach in Ayurveda, aiming to eliminate causative factors (Nidan Parivarjana), enhance digestive fire (Dipan), aid in the digestion of toxins (Pachan), normalize Vata movement downward (Anulomana), and facilitate stool expulsion through procedures like Bhedana and Rechana3. Ayurveda views constipation not merely as a local issue but as a reflection of overall imbalance in the body. This perspective allows for treatments that address the root cause of Vibandha, promoting long-term health without adverse side effects. Additionally, Ayurvedic remedies are considered safe and effective alternatives for managing constipation, particularly when gentle, natural approaches are preferred. The global impact of childhood constipation is frequently underestimated, largely due to limited data availability within this age group4. Epidemiological studies use various definitions, ranging from the established Rome criteria to parent-reported proxies. A recent systematic review in pediatric populations indicated constipation prevalence ranging widely from 4% to 29.6%5. This variation in prevalence can be attributed not only to differing definitions but also to variations in symptom duration required for diagnosis, age distributions of study participants, and methods of data collection. Chronic constipation in children is when a child experiences two or more of the following symptoms for at least two months: fewer than three bowel movements per week, accidental leaking of stool more than once a week, stool getting stuck in the rectum, passing stool so large that it clogs the toilet, holding in stool on purpose, and pain during bowel movements. About 60% of children with constipation may experience overflow incontinence, where stool leaks out due to a build-up in the rectum. Most cases of constipation in children are due to holding in stool,either on purpose or without realizing it. About 2% of healthy primary school children have this condition, with boys being affected up to four times more often than girls.
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
- 2.00 Year(s) 至 6.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient age group 2-6 years irrespective of sex, religion and economical status 2.Children fulfilling the ROM III criteria30 or patient presenting sign and symptoms of vibandha.
- •3.Parents/ Guardians of the child willing to participate in clinical trial/study with written consent.
排除标准
- •Patients having Constipation due to severe illness related to Anorectal Conditions and organic disorders like Hirschsprung disease.
- •Patients with Rectal Prolapse, IBD, Malignancy, endocrinal disease etc or any other systemic illness.
- •Patient on any other long-term medications.
- •Patient known case of Neuromuscular disease like cerebral palsy.
结局指标
主要结局
DRAKSHA SYRUP is effective in Vibhandha in children within 7 days
时间窗: Follow up will be done on 0 , 3 and 7 day and outcome will be recorded.
That is, the main efficacy outcome used for sample size estimation is the mean change in spontaneous bowel movements per week from baseline to day 7.
时间窗: Follow up will be done on 0 , 3 and 7 day and outcome will be recorded.
次要结局
- LACTULOSE SYRUP is effective in Vibhandha in children(Patient will be assessed on 0, 3 & 7 th day)
研究者
ARBAZ ISAQ SHAIKH
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON
