Using Sivathai Chooranam, a Siddha formulation in opioid induced constipation – A prospective, interventional study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients constipated at the end of 48 hours and 96 hours based on Rome IV criteria
研究概览
简要总结
- Origin of the proposal - The Rome IV criteria (panel) defines opioid-induced constipation as a change in baseline bowel habits or defecatory patterns following initiation, alteration, or increase in opioid therapy. Opioid induced constipation(OIC) is a common side effect which occurs in patients for whom opioids are used in the management of pain. The prevalence of OIC among cancer patients receiving opioids is between 74 – 87%. So it is mandatory to prescribe laxatives prophylactically while prescribing opioids. The standard prescription includes stimulant laxatives like bisacodyl or sodium picosulfate.
2. Definition of the problem - Sivathai chooranam is a siddha medicine, consisting of 11 natural ingredients is proven to be effective in the management of functional constipation. But the efficacy of the same in management of OIC has not been studied yet. It has both laxative and anti-diarrhoeal properties even though it has been prescribed only for management of constipation along with warm water. If proven effective this can be a cheaper and natural alternative to the current management of OIC and a more acceptable one given our cultural context.
3. Objective - To assess the safety and efficacy of sivathai chooranam in opioid induced constipation for cancer patients requiring opioid analgesics
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of cancer and prescribed morphine for the management of pain for the first time
- •Patients who can take medications orally or through feeding tubes(NG tube/ NJ tube/ PEG)
- •modified Karnofsky Performance Status more than or equal to 40
- •Patients with normal cognitive function.
排除标准
- •Patients who are already having chronic constipation (Type 1 and 2 based on Bristol stool form scale) and receiving laxatives for the same
- •Patients who are currently having diarrhoea or stool consistency Type 6 and 7 based on Bristol stool form scale
- •Patients having Diabetes Mellitus and undergoing treatment for the same
- •Patients with impaired liver function or liver failure
- •Patients having acute or unstable liver injury/damage
- •Patients having medical renal disease / renal failure.
结局指标
主要结局
Proportion of patients constipated at the end of 48 hours and 96 hours based on Rome IV criteria
时间窗: 48 hours and 96 hours
次要结局
- Patient reported side effects of sivathai chooranam(12 weeks)
- Average dose of sivathai chooranam required(12 weeks)
- Number of times laxatives needed(Every week for 12 weeks)
- Consistency of stools based on Bristol stool form scale(At the beginning, 48 hours, 96 hours, and at week 1, 4 and 12)
- Change in average Bowel Function Index(BFI) score(At the beginning, 48 hours, 96 hours, and at week 1, 4 and 12)
研究者
Daniel Raj Joseph Thangasamy
Cancer Institute WIA