A study to find out the effect and safety of Amlapitta Mishran Suspension in patients with gastritis (stomach inflammation).
- Conditions
- Health Condition 1: K297- Gastritis, unspecified
- Registration Number
- CTRI/2020/02/023224
- Lead Sponsor
- Shree Dhootapapeshwar Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Presence of endoscopic gastritis, as diagnosed by the Sydney classification.
2. Participants with normal electrocardiogram (ECG) report.
3. Participants willing to give written informed consent.
4. Participants willing to follow up.
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.
25.Participants with history of severe allergy or anaphylactic reaction.
26.Participants who cannot give valid consent such as mentally retarded, unconscious participants and psychiatric illness.
27.Known history of positive screening result for hepatitis B and/or Hepatitis C virus.
28.History of HIV or any immune deficient conditions.
29.Participants that investigators consider ineligible for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method