CTRI/2022/05/042670尚未招募4 期
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
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
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.
- •4.Participants willing to give written informed consent.
- •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.
- •14.Participants taking other investigational drugs within 30 days prior to the study.
- •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.
- •24.Participants with history of severe allergy or anaphylactic reaction.
- •25.Participants who cannot give valid consent such as mentally retarded, unconscious participants and psychiatric illness.
- •26.Known history of positive screening result for hepatitis B and/or Hepatitis C virus.
- •27.History of HIV or any immune deficient conditiOns.
研究者
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