A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL ON THE EFFICACY OF MARICHADI GUTIKA AND MANDOOKPARNI VATI IN THE MANAGEMENT OF IBS IN CHILDREN
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is a double blind randomized clinical trial planned to evaluate the efficacy of Marichadi Gutika and Mandookparni Vati in the management of Irritable Bowel Syndrome in children. Irritable Bowel Syndrome is a common functional gastrointestinal disorder characterized by recurrent abdominal pain associated with altered bowel habits without any structural abnormality. It significantly affects the physical growth emotional wellbeing and quality of life of children. Modern medicine mainly focuses on symptomatic relief whereas Ayurveda explains this condition under the concept of Grahani Roga which occurs due to impairment of digestive fire influenced by improper diet lifestyle and mental stress.
The trial will be conducted on children aged six to twelve years diagnosed with Irritable Bowel Syndrome according to Rome Four criteria. A total of sixty patients will be randomly divided into two groups receiving either Marichadi Gutika or Mandookparni Vati for a period of seventy five days. Both medicines are selected for their digestive stimulant bowel regulating and mind calming properties. Regular follow up and assessment will be done based on clinical symptoms such as abdominal pain bowel irregularity appetite and general weakness.
The study aims to provide scientific evidence for the effectiveness and safety of Ayurvedic formulations in managing Irritable Bowel Syndrome in children and to improve their overall quality of life through a holistic approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •patients having age between 6-12yr ,irrespective of sex,religion,occupational and socio-economic status 2)patient having more than or equal to 50% of subjective parameter will be included in the study.
- •Having history of recurrent abdominal pain at least 2 month before diagnosis.
- •History of evacuation after taking meal.
- •patient willing to participate in the research trial.
排除标准
- •Patients having age below 6 year and above 12year.
- •Red Flag in Diagnosing IBS -Confirmed weight loss -Symptoms persistent or worse at night (child wakes up with pain) -Unexplained anemia -Bleeding per rectum.
- •Severe diarrhea and/or vomiting -Unexplained fever -Strong family history of inflammatory bowel disease 3)Children having already history of metabolic disorders and systemic disorder like TB, DM etc.
- •will be excluded from the study.
- •Children suffering from congenital anomalies, acute infectious disease.
研究者
Dr Pooja Singh
State Ayurvedic college and hospital Lucknow