Health Condition 1: K297- Gastritis, unspecified
Conditions
Interventions
Intervention1: Amlapitta Mishran Suspension: Amlapitta Mishran 15 ml suspension orally before meals twice daily for 30 days.
Ayurved Proprietary Medicine containing Shouktik Bhasma (Processed Shell) a
Sponsors
Shree Dhootapapeshwar Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants showing improvement in endoscopic gastritis.Timepoint: Baseline and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants showing improvement of Amlapitta symptom rating scale. 2. Percentage of participants showing improvement in Postprandial Distress Syndrome symptom scale. 3. Percentage of participants showing improvement in Epigastric Pain Syndrome symptom scale.Timepoint: Baseline, Day 15 and Day 30 [Every 2 weeks] | — |
Countries
India
Contacts
Public ContactDr Mukesh Chawda
Shree Dhootapapeshwar Limited
Outcome results
None listed