Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Eradication of H. Pylori
研究概览
简要总结
Helicobacter pylori (H. pylori) is a bacterium its infection is regarded the most common medical condition associated with gastritis1 more over peptic ulcer disease2, gastric adenocarcinoma3 and lymphoma.4control of H pylori infection is thought to be the solution of public health problem.5,6 rate of infection is abating in developed world 7 , but this is slow and people health is challenged, to stop or decrease the new cases is complicated despite the fact that route of transmission are still unclear .8-10 The only option for reducing incidence and prevalence is that screening of masses followed by eradication therapy. A rough estimate propose about 50% of developing country population is affected from infection than the industrialized country. Infected individual may be asymptomatic or some time present with gastroduodenal disease. Prevalence of H pylori is different in developing countries where the adult prevalence reaches up to 80% and in children it is found before the age of 10 years.
详细描述
Helicobacter pylori (H. pylori) is a bacterium its infection is regarded the most common medical condition associated with gastritis1 more over peptic ulcer disease2, gastric adenocarcinoma3 and lymphoma.4control of H pylori infection is thought to be the solution of public health problem.5,6 rate of infection is abating in developed world 7 , but this is slow and people health is challenged, to stop or decrease the new cases is complicated despite the fact that route of transmission are still unclear .8-10 The only option for reducing incidence and prevalence is that screening of masses followed by eradication therapy. A rough estimate propose about 50% of developing country population is affected from infection than the industrialized country. Infected individual may be asymptomatic or some time present with gastroduodenal disease. Prevalence of H pylori is different in developing countries where the adult prevalence reaches up to 80% and in children it is found before the age of 10 years.
Aims and objectives
- To establish and evaluate scientific and clinical evidence of herbal/eastern formulation and find out the clinical safety and efficacy.
- To measure the clinical response of herbal formulation in the patients of H.Pylori.
Research Questions
- has the Unani formulation better effects than quadruple regimen?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The individuals suffering from H. pylori infection .
- •Individuals having no previous history of H. pylori infection treatment.
- •Individuals living in Karachi.
- •Individuals with no pathological finding on routine examination.
- •Individuals from either socioeconomic class including lower, middle and higher.
- •Both male and female individuals between 14 to 55 years of age
- •Subjects with informed written consent
- •Patients having no complications regarding other than GIT system.
- •Exclusion Criteria
- •The following were the reason for excluding the individuals from this trial:
- •Patient with simultaneous physical illness, for example renal dialysis and uncontrolled diabetes mellitus.
- •Individuals having stomach or intestinal surgical history were excluded.
- •Individuals with past record of any herbal or allopathic medication were excluded
- •Individuals with hyper sensitivity history of drug or adverse reaction to any of the study drugs .
- •Females with pregnancy were also excluded for the safety measures
- •Individuals with coma, meningitis, and encephalitis or head injury were also excluded.
- •Hospitalized individuals due to any serious diseases were excluded.
- •Individuals with known poor compliance and history of drug abuse were excluded.
排除标准
- 未提供
研究组 & 干预措施
Test Drug
This group is treated with Herbal formulation.
干预措施: Pylorin (Drug)
Control Drug
This group is treated with Quintuple therapy
干预措施: Pylorin (Drug)
结局指标
主要结局
Eradication of H. Pylori
时间窗: 4 week duration
Negative Stool antigen for H. pylori
次要结局
未报告次要终点
研究者
Syed Zahoor Ul Hassan Zaidi
Syed Zahoor Ul Hassan Zaidi
Hamdard University