Randomised comparative study of Homoeopathic individualized centesimal potencies vs LM-potencies in patients with Post-cholecystectomy syndrome with special reference to dyspepsia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dyspepsia Severity Assessment Score
研究概览
简要总结
Abdominal symptoms persist in up to 40% of patients after laparotomy cholecystectomy and biliary lithotripsy. Laparoscopic cholecystectomy is now the treatment of choice for symptomatic gallstone disease. However, no data exist as to the influence of laparoscopic cholecystectomy on symptoms1.Symptoms include biliary or non-biliary-like abdominal pain, dyspepsia, vomiting, gastrointestinal disorders, and jaundice, with or without fever and cholangitis. This group of abdominal symptoms which recur or persist after cholecystectomy is termed as Post-cholecystectomy syndrome (PCS). It may occur early during the post-operative period and if late it may manifest after months or years. Probably because of the uncertainty in nosographic definition, the reported prevalence of PCS ranges from very low and is 5to 40 %. Clinical experiences prove efficacy of Homoeopathy medicines in gastro-intestinal symptoms related to PCS as evident from Homoeopathic materia medica and published articles. Moreover, one of the aspects in fundamentals of Homoeopathy is Posology and in which the effect of individualized homoeopathic intervention in LM and CH potencies is always a dilemma i.e., which potency acts better. Both the scales of potency were discovered by Hahnemann, although the former scale of potency is the latest and were published posthumously. In this project we intend to compare the effectiveness of the two different scales of potencies in post cholecystectomy cases and for that 30 patients will be randomly selected in intervention and comparative group and based on Dyspepsia Severity Assessment Score at baseline, 3rd month, 6th month, 9th month and 12th month the evaluation will be done at the study centre i.e. Dr Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata. It is randomised (1:1), open labelled comparative trail. The generated results will undergo statistical analysis and will be published in scientific journal.
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
- 20.00 Day(s) 至 60.00 Day(s)(—)
入选标准
- •• Age: 20 years -60 years, Gender: male and female • Patient underwent cholecystectomy (Open or Laparoscopic) at least minimum of 2 months ago and maximum of 20 years ago.
- •• Patient with features of dyspepsia with or without jaundice.
排除标准
- •• Post-cholecystectomy syndrome cases arising due to biliary stricture, fistula, perforation, chronic pancreatitis, Cholangitis, Helicobacter pylori infection, retained or dropped stone.
- •• Incidental Gall Bladder Cancer (IGBC) after cholecystectomy • Pregnant and lactating women.
结局指标
主要结局
Dyspepsia Severity Assessment Score
时间窗: At baseline, 3rd month, 6th month, 9th month and 12th month
次要结局
- The Gastrointestinal Quality of Life Index (GIQLI)(At baseline, 3rd month, 6th month, 9th month and 12th month)
研究者
Dr Partha Pratim Pal
Central Council for Research in Homoeopathy
