A Comparative Randomized Clinical Study to evaluate the Efficacy of Unani formulations used in H.pylori induced Gastritis.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Endoscopic findings
研究概览
简要总结
Upper gastrointestinal (GI) inflammatory conditions are a group of disorders characterized by inflammation of the upper digestive tract. Endoscopy plays a vital role in confirming the diagnosis and assessing the severity of upper GI inflammatory conditions such as esophagitis, gastritis, duodenitis, and peptic ulcers thus, allowing for precise intervention strategies.
The most common complaint of upper gastrointestinal disorders globally is dyspepsia. Dyspepsia according to RomeIII criteria should include 1 or more of the following 3 symptoms for 3 months within 6 months of symptoms initial onset. Upper GI symptoms like dyspepsia, heartburn, pain in abdomen and hematemesis are some of the common complaints with which patients present to the surgery OPD. Dyspepsia has a great socio-economic impact as it impairs the quality of life and adds to the financial burden due to repeated hospital visits and medications.
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
- 14.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Endoscopic Diagnosis: H.
- •pylori induced gastritis patients diagnosed on endoscopy using Rapidurease test (RUT) kit and histopathology.
- •Patient given written consent.
排除标准
- •Patients of age below 14years.
- •Pregnant and lactating mothers.
- •Patient sensitive to any of the test or standard drugs included in the study will be excluded along with appropriate treatment, as and when required.
- •Severe Comorbidities: Participants with severe comorbidities such as advanced malignancies, severe cardiac, hepatic, renal diseases,Tuberculosis, Acute or Chronic Ulcerative colitis, Cohn’s disease, Positive case of Venereal disease, HIV and HBsAg in including Diabetes.
- •Allergies and Intolerances: Known allergies or intolerances to medications used for the treatment of upper GI inflammatory conditions or H.
- •pylori eradication.
- •Already taken PPI [H.PYLORI] Kit.
结局指标
主要结局
Endoscopic findings
时间窗: At the time of First visit and than after three months of the treatment.
H. Pylori RUT kit
时间窗: At the time of First visit and than after three months of the treatment.
次要结局
- Dyspepsia(Pain Abdomen)
研究者
Nida Saeed
Aligarh Muslim University