A Prospective, Multi Centre, Open label, Single arm Study to Evaluate the Efficacy and Safety of Amlapitta Mishran Suspension in Participants with Amlapitta (Symptomatic Gastritis).
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- To evaluate efficacy of Amlapitta Mishran Suspension in improvement of Amlapitta Symptom Rating Scale Score from baseline to Day 14.
研究概览
简要总结
Functional Dyspepsia is divided into Postprandial Distress Syndrome (PPDS) and Epigastric Pain Syndrome (EPS). The broad term functional dyspepsia comprises participants from the diagnostic categories of PDS, which is characterized by meal-induced dyspeptic symptoms; EPS, which refers to epigastric pain or epigastric burning that does not occur exclusively postprandially, can occur during fasting, and can be even improved by meal ingestion, and overlapping PDS and EPS, which is characterized by meal-induced dyspeptic symptoms and epigastric pain or burning [3]. Modern medicine offers may drugs / medicaments for the management of Acid Peptic Disorders like gastritis, but their safety may be a cause of concern. Thus, there is need for a new drug with lower side effect profile and good efficacy. Ayurved the ancient Indian system of medicines is a rich database of herbal, mineral and animal origin raw materials / ingredients for the management of acid peptic disorders. Amlapitta is the nearest correlate to acid peptic disorders mainly gastritis and many Ayurved ingredients are extensively studied and documented for their acid neutralising, cytoprotective and ulcer healing potential. Therefore, the current study is planned to evaluate the efficacy and safety of Amlapitta Mishran Suspension in participants with symptomatic gastritis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants of either sex in the age group of 18-65 years.
- •2.Presence of Amlapitta (symptomatic gastritis), as diagnosed by the Amlapitta Symptom Rating Scale Score ≥ 5 [with Tikta-Amla Udgaar (Sour and bitter belching) and Hrit-Kantha Daha (Burning Sensation) Score ≥ 1].
- •3.Participants with normal Electrocardiogram (ECG) report.
- •Participants willing to follow up.
排除标准
- •1.Pregnant or lactating women.
- •2.Participants who have previously received Amlapitta Mishran Suspension.
- •3.Participants with documented H.
- •pylori infection.
- •4.Participants with psychiatric disorders including eating disorders.
- •5.Participants with chronic degenerative diseases including uncontrolled hepatic, renal or endocrine diseases (except diabetes controlled by oral hypoglycaemic agents or controlled hypothyroidism), malabsorption or chronic diarrhoea, history of seizures or epilepsy, gastric surgery or participants with oncological diseases.
- •6.Participants with previous allergic reactions to any components of Amlapitta Mishran Suspension.
- •7.Participants with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy).
- •8.Participants with history of oesophageal varix (varices) 9.Participants with history of malignant neoplasm of gastrointestinal tract.
- •10.Participants with history of thrombosis or administered with anti-thrombotic drugs.
- •11.Participants with coagulation disorders 12.Participants administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 1 weeks.
- •13.Participants who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment.
- •15.Participants with history of Zollinger-Ellison syndrome 16.Participants with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
- •17.Participants with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the participant from the study.
- •18.Participants with laboratory parameters of Liver function test more than 1.5 times the upper limit of normal or detected any time during the study period will lead to exclusion of the participant from the study.
- •19.Participants with Serum Creatinine more than 1.5 mg/dl, detected any time during the study period will lead to exclusion of the participant from the study 20.History of life threatening cardiovascular and /or neurological event in the past one year.
- •21.Participants with history of alcohol or drug abuse, bleeding disorder.
- •22.Participants having any severe active infectious disease requiring hospitalization.
- •23.Participants who have taken test medication or any oral herbal medication in the past 4 weeks.
- •25.Participants who cannot give valid consent such as mentally retarded, unconscious participants and psychiatric illness.
- •27.History of HIV or any immune deficient conditiOns.
结局指标
主要结局
To evaluate efficacy of Amlapitta Mishran Suspension in improvement of Amlapitta Symptom Rating Scale Score from baseline to Day 14.
时间窗: Amlapitta Symptom Rating Scale Score from baseline to Day 14.
次要结局
- 1.To evaluate efficacy of Amlapitta Mishran Suspension in improvement of Post Prandial Distress Syndrome (PPDS) score from baseline to Day 14.(2.To evaluate efficacy of Amlapitta Mishran Suspension in improvement of Epigastric Pain Syndrome (EPS) score from baseline to Day 14.)