Clinical Efficacy Assessment of Alsareen Capsule for the Management of Helicobacter Pylori (H. Pylori) Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- H. pylori stool for antigen test will screened before and after treatment.
研究概览
简要总结
Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. More than 50% of the global population is estimated to be infected. In 2015, there were approximately 4.4 billion individuals with H pylori infection worldwide. In Pakistan the prevalence of H. pylori infection, highest (63%) in middle age (41-60 years) group while lowest (33%) in teens and pre-teens (<20 years) group. In young age (20-40) and old age (>60 years) groups, the prevalence of H. pylori was 55% and 60% respectively.
In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects & a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy.
详细描述
Introduction:
Peptic ulcers are open sores that develop on the inside lining of stomach and the upper portion of small intestine. The most common symptom of a peptic ulcer is stomach pain. Peptic ulcers include; Gastric ulcers that occur on the inside of the stomach and Duodenal ulcers that occur on the inside of the upper portion of small intestine (duodenum). The most common cause of peptic ulcers infection is the bacterium Helicobacter pylori (H. pylori). Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. The World Health Organization has declared H. pylori as a Class 1 carcinogen.
In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects & a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy.
Alsareen is a DRAP registered product of Hamdard Laboratories (Waqf) Pakistan (HLWP). Alsareen is a time tested formulation developed at Hamdard Research Center and it is being used clinically for more than 15 years. This formulation was shared for broader use at Hamdard Matabs since 1.5 years and found satisfactory. The study will be conducted at Shifa ul Mulk Memorial Hospital Hamdard University, Hamdard Matab Nazimabad and Hamdard Matab Arambagh. The sample size of 50 Subjects suffering from H. pylori Infection will be study and managed by Unani Medicine 'Alsareen'.
Epidemiology:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects suffering from H. pylori Infection.
- •Subjects having positive test for stool Ag of H. pylori.
- •Subjects over 15 years of age.
- •Subjects agree to use Test Drug throughout the study.
- •Subjects of both sexes are involved.
排除标准
- •Subjects suffering from chronic liver diseases and kidney failure.
- •Subjects currently taking any antibiotics.
- •Subjects suffering from any type of cancer and any other comorbid condition.
- •Subjects having history of adverse drug reaction.
- •Pregnant & lactating mother.
结局指标
主要结局
H. pylori stool for antigen test will screened before and after treatment.
时间窗: 42 days
after administering medication, the H. pylori stool antigen test yielded a negative result, indicating the absence of H. pylori antigens in the stool sample.
次要结局
未报告次要终点
研究者
Anees ur Rehman
Principal Investigator
Hamdard University