Safety Trial of Herbal Melanin in Gastritis Patients (NCT03428568) | Clinical Trial Compass
UnknownPhase 2
Safety Trial of Herbal Melanin in Gastritis Patients
132 participantsStarted 2018-03
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants cured from acidity symptoms and H.Pylori -induced gastritis
Timeframe: 6 months
Trial details
NCT IDNCT03428568
SponsorKing Abdullah International Medical Research Center