跳至主要内容
临床试验/CTRI/2024/12/077660
CTRI/2024/12/077660招募中不适用

Efficacy of Homoeopathic Treatment in Gastroesophageal Reflux Disease using GERD Questionnaire

Vinayaka Mission Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
38
试验地点
1
主要终点
Reduction in GERD symptoms

研究概览

简要总结

Gastro-oesophageal reflux disease( GERD) is a commonly prevailing disease in the recent times owing to the fast paced urbanized way of living where emphasis on proper diet and lifestyle has been constantly being overlooked. Gastro-oesophageal reflux disease is identified by the presence of characteristic symptoms of heartburn, regurgitation of ingested food or acidic regurgitation and upper abdominal pain, in some cases presence of chronic cough and difficulty in swallowing is observed. Owing to the uncertainty in availability of invasive tests in primary care units, patient’s discomfort and high financial requirement of endoscopic studies, the need of non-invasive diagnostic measures such as scales and questionnaires have raised.A need arises to minimise the usage of invasive measures and at the same time to arrive at a satisfactory diagnosis. Various approaches have been devised to diagnose GERD without resorting to invasive procedures. Questionnaires represent one such method, enabling an objective evaluation of symptoms. These questionnaires typically comprise a series of inquiries to gauge severity (often utilizing scales like Likert’s scale), frequency, associated phenomena, nighttime symptoms, and occasionally quality of life. The benefits of questionnaires lie in their self-administration capability, utility as screening instruments, affordability, and applicability to any individual experiencing GERD symptoms. Based on the DIAMOND ROC analysis, logistic regression and relevance, as well as data from previous studies and qualitative interviews, six items from the different questionnaires were included in the new questionnaire, GerdQ contains 6 questions, which comprises four positive predictors of GERD: heartburn and regurgitation (the two characteristic symptoms of GERD, according to the Montreal definition), sleep disturbance because of these two reflux symptoms and two negative predictors of GERD, epigastric pain and nausea. Patients were asked to reflect on symptoms over the preceding week. Scores ranging from 0 to 3 were applied for the positive predictors and 10from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18.The Homoeopathic medicine will be prescribed on the basis of Constitutional totality followed by scoring in GERD Questionnaire.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with symptoms of Heartburn and or regurgitation for minimum of six weeks and at least two episodes per week and GERDQ score of 8 and more.

排除标准

  • Patients with history of gastric surgery Patients with cardiac, pulmonary, hepatic or renal diseases.
  • Pregnant and lactating women Patients with autoimmune diseases Patients with alarming symptoms such as severe dysphagia, hematemesis, anemia, acute weight loss,nausea and incessant vomiting.

结局指标

主要结局

Reduction in GERD symptoms

时间窗: 6 months

次要结局

  • Reduction in GERD Questionnaire score(6 months)

研究者

发起方
Vinayaka Mission Homoeopathic Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shameer Nawaz S

Vinayaka Mission Homoeopathic Medical College And Hospital

研究点 (1)

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