An Open Labelled Randomised Active Controlled Clinical Study Of Iltihab Ul Meda Bis Sabab Wa Taseerul Muzirrat Bil Advia (Drug Induced Gastritis) With Compound Unani Formulation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To diagnose te patient based oh LDQ scale (leeds Dyspepsia quesionnare) and symptoms
研究概览
简要总结
In unani, gastritis or warm-e- meda, as unani physicians has mentioned the gastritis by different names Hirqat-e-meda, Sozish-e-meda, warm-e-meda and iltehab-e-meda
According to concept, warm-e meda is condition in which there is inflammation of mucous membrane of stomach.
The compound unani formulation Sufoof-e-Vaj (which has been through pre clinical trail) is selected to prove its efficacy in comparison with standard drug Pantoprazole in treatment of drug induced gastritis
Medication induced GI symptoms & endoscopic pathology are commonly encountered in clinical practice. Over 35 million people consume drugs daily & about 25% of which may develop gastritis
According to data published by gastroenterology research done at National level it stated that the total population who consume NSAIDs of which 30.08% of patiets are seen with GI Complications.
While awareness of GI adverse effects of some medications are well recognized, other medications that are commonly used and cause GI symptoms frequently such as metformin, are arguably underappreciated Medication produced symptoms by altering GI physiology and by causing tissue damage
To clinically evaluate the efficacy of Unani formulation in management of ILTIHAB-UL-MEDA BIS- SABAB WA TASEERUL-MUZIRRAT BIL- ADVIA (DRUG INDUCED GASTRITIS ) with sample size of 40 and 2 duration with some inclusion and exclusion criteria (mentioned in part-6)
The study has been planned
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with following Complaints Of:
- •Epigastric Pain 2.Nausea 3.Vomiting 4.Indigestion 5.Heart Burn
- •Loss of Appetite
- •Eructation Patient with Drug History of NSAIDS for more than 3months.
排除标准
- •1.Pregnant and lactating women
- •Patient with H.pylori 3.Uncontrolled hypertension and diabetes 4.Patients with: Active GI bleed Obstruction and perforation Gastric carcinoma 5.Previous h/o smoking and alcohol 6.Recent use of antibiotics 7.Patients with renal, cardiac, pulmonary and other systemic diseases.
结局指标
主要结局
To diagnose te patient based oh LDQ scale (leeds Dyspepsia quesionnare) and symptoms
时间窗: once in 2 weeks
次要结局
- To prove / show the comparative study results in cases of Drug Induced Gastritis(once in 2 weeks)
研究者
Dr Shams Unnisa
Government Nizamia Tibbi College