Status:
UNKNOWN
Safety Trial of Herbal Melanin in Gastritis Patients
Lead Sponsor:
King Abdullah International Medical Research Center
Conditions:
Acid Dyspepsia
Gastritis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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.p...
Detailed Description
Background: The melanin to be used in this study is a herbal melanin (HM) that has been extracted from the plant Nigella sativa. Nigella sativa was obtained from local market in Riyadh, Saudi Arabia....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03428568
Start Date
March 1 2018
End Date
March 1 2020
Last Update
February 9 2018
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