A prospective, single centre, open label, single arm study to Evaluate the Efficacy and Safety of Amlapitta Mishran Suspension in Participants with Endoscopic Gastritis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of participants showing improvement in endoscopic gastritis.
研究概览
简要总结
Amlapitta Mishran Suspension is a marketed Ayurvedic Proprietary Medicine prescribed by Ayurved Practitioners across India for the management of acid peptic Disorders. Amlapitta Mishran Suspension is documented for its anti-ulcer effect in experimental model of indomethacin induced gastric ulcers in rats. The ingredients like Vasa (Adhatoda vasica), Guduchi (Tinospora cordifolia), Kiratatikta (Swertia chirata), Nimba (Azadirachta indica), Patola (Trichosanthes dioica), Yashti (Glycyrrhiza glabra) in Amlapitta Mishran Suspension are documented for their anti-ulcer effect. Bhrungaraja (Eclipta alba), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica) and Amalaki (Emblica officinalis) possess gastroprotective activity. Shouktik (Muktashukti) Bhasma (Processed Seashell) has acid neutralising effect and in experimental model is documented for its anti-ulcer activity. Keeping in mind the healing potential of the components of Amlapitta Mishran Suspension this study was planned to evaluate its potential in participants with endoscopic gastritis. Additionally, it will also be evaluated on parameters like Amlapitta symptom rating scale, Post Prandial Distress Syndrome (PPDS) score, Epigastric Pain Syndrome (EPS) score from baseline to day 15 and 30 days. Its safety will be assessed on clinical and laboratory parameters (CBC, LFT and RFT), physical examinations and vital signs (body temperature, pulse) from baseline to day 15 and 30 days. The dosage of Amlapitta Mishran Suspension will be 15 ml orally before meals twice daily for 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of endoscopic gastritis, as diagnosed by the Sydney classification.
- •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 who have contraindications to undergo endoscopy.
- •8.Participants with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy).
- •9.Participants with oesophageal varix (varices) 10.Participants with malignant neoplasm of gastrointestinal tract.
- •11.Participants with thrombosis or administered with anti-thrombotic drugs.
- •12.Participants with coagulation disorders 13.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.
- •14.Participants who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment.
- •15.Participants taking other investigational drugs within 30 days prior to the study.
- •16.Participants with Zollinger-Ellison syndrome 17.Participants with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
- •18.Participants with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the participant from the study.
- •19.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.
- •20.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.
- •21.History of life threatening cardiovascular and /or neurological event in the past one year.
- •22.Participants with history of alcohol or drug abuse, bleeding disorder.
- •23.Participants having any severe active infectious disease requiring hospitalization.
- •24.Participants who have taken study drug or any oral herbal medication in the past 4 weeks.
- •26.Participants who cannot give valid consent such as mentally retarded, unconscious participants and psychiatric illness.
- •28.History of HIV or any immune deficient conditions.
- •29.Participants that investigators consider ineligible for this study.
结局指标
主要结局
Percentage of participants showing improvement in endoscopic gastritis.
时间窗: Baseline and Day 30
次要结局
- 1. Percentage of participants showing improvement of Amlapitta symptom rating scale.(2. Percentage of participants showing improvement in Postprandial Distress Syndrome symptom scale.)