Safety Trial of Herbal Melanin in Gastritis Patients

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to use Melanole, a herbal extract from Nigella sativa, for treatment of gastritis. The effect of Melanole will be compared between participants (including H. pylori and non-H.pylori infected patients), with the triple therapy and Standard of care treatment of gastritis, respectively.

All participants will be examined before and after the administration of Melanole. The results showing a relief of gastritis symptoms for non-H. pylori patients and partial or complete eradication of H. pylori for H.pylori infected patients will be evaluated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Abdullah International Medical Research Center
• Treatments: Amoxicillin; Clarithromycin; Esomeprazole; Omeprazole

Criteria

Inclusion Criteria:

• Males or Females between 18- 60 years

• Willing to sign Informed Consent Form (ICF)

• Women of Child bearing age will be asked to conduct a pregnancy test before enrolling in the study and offered contraceptives for the duration of the study participation

• Clinical Pictures of Gastritis.

• Histologically confirmed H- Pylori Gastritis or Non H- Pylori by one week from enrollment.

Exclusion Criteria:

• Patients with disturbed gastrointestinal physiology (gastric surgery, vagotomy, Zollinger-Ellison syndrome)

• Patients who have been treated with proton pump inhibitors during 3 weeks prior to inclusion

• Patients who have been treated with antibiotics or bismuth containing drugs 1 month prior enrolling in the study

• Patient with pyloric stenosis

• Patient with Hematologic disorder

• Patient with congestive heart disease

• Women who are pregnant or lactating

• Current or past history of malignancy

• Drug abuser and chronic alcoholism

• Patients currently participating in any other clinical trial of any kind