A randomised controlled clinical trial to study the effect of Ruchakadi Churna In Malavibandha with special reference to functional constipation in children.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Reduction in delay or difficulty in defecation after giving Ruchakadi churna.
研究概览
简要总结
The prevalance of functional constipation is 14.4 percent. functional constipation is regarded as a distint condition and if not treated properly can lead to several disease. Ruchakadi churna have properties like deepan and pachan and having a snigdha guna which help in passing of stool and reduce the symptoms of constipation.
Null Hypothesis Ruchakadi churna is not effective in Malavibandha (functional constipation) in children.
Alternative Hypothesis Ruchakadi churna is effective in Malavibandha (functional constipation) in children.
Conducting research to evaluate the effectiveness of Ruchakadi churna in treating functional constipation is crucial for expanding our understanding of traditional remedies and their applications in modern healthcare. By filling the knowledge gap, the study can provide valuable insights into the potential benefits of Ruchakadi Churna and its role in managing constipation.
Including patient within the age group 4 years to 16 years who fulfill the clinical diagnostic criteria for functional constipation patients are selected irrespective of sex, socio-economic status and community helps in achieving a diverse and representative sample, written consent from parents ensures ethical compliance and transparency in the treatment process. SAMPLE SIZE using formula Daniel 1999 the calculated sample size is 47. Simple random sampling technique will be used. Total 94 numbers of patients will be selected and divided into two groups named as Gruop A (trial group) and Group B (Control group). Ruchakadi Churna Group A and Vaishvanar churna Group B will be given to patients.Trial and control drugs will be purchased from GMC certified pharmacy.
Both drug will be administered in churna form for 7 days. All SOP of churna vidhi will be strictly followed during and after treatment. Observations will be done on Day 0, Day 7 and day 14. Result of the study will draw on basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of ststistical analysis and will be unbiased.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children fulfilling ROME IV Criteria (Must include 2 or more of the following symptoms over preceding 3 months in a child with developmental age is at least 4 years or above) 2.Fewer than 3 spontaneous bowel movements per week.
- •3.Straining for more than 25 % of defecation attempts.
- •4.Lumpy or hard stools for at least 25 % of defecation attempts.
- •5.Sensation of anorectal obstruction or blockage for at least 25 % of defecation attempts.
- •6.Sensation of incomplete defecation for at least 25 % of defecation 7.Manual maneuvering required to defecate for at least 25 % of defecation attempts.
排除标准
- •1.A patient having associated symptoms of other systemic disease.
- •2.Hormonal diseases such as known case of Hypothyroidism etc.
- •3.Drug induced.
- •4.Life threatening systemic infection like HIV.
- •5.Patient who needs to be hospitalized.
- •7.Patients with congenital anomalies that affect the anal area.
结局指标
主要结局
Reduction in delay or difficulty in defecation after giving Ruchakadi churna.
时间窗: 14 Days
次要结局
- comparison with trial and control groups.(18 months)
研究者
Dr Madhuri Bapusaheb Kadlag
SMBT Ayurved College and Hospital