Safety Trial of Herbal Melanin in Gastritis Patients (RASATHEME)

February 4, 2018 updated by: King Abdullah International Medical Research Center

Open Label, Randomized, Single Site Clinical Trial To Compare The Safety Of Herbal Melanin Extracted From Nigella Sativa Seeds Vs Standard Of Care Treatment In Treating Gastritis Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. HM has been obtained from seed total powdered extract using standard extraction procedure and has been reported as a patent for the first time.The percentage of pure melanin in total Nigella sativa L. is 9% as identified using Electron Spin Resonance (ESR) and Fourier Transform- Infra Red (FI-IR) and calculated using wet chemical methods. Three different patches of Nigella sativa L that were obtained from different Nigella sativa L species were tested (Saudi, Ethiopian and Indian) and the same percentage of HM was obtained. The safety of HM has been tested and confirmed by different labs including lab for Quality and Safety and Industrial Research Institute(IRI) (see supplements 1 and 2). Similarly, the safety of the HM capsules have been tested at the Toxicology and Bioanalysis in King Faisal Specialist Hospital(KFSH) (see supplement 3). Moreover, the capsules have been approved and certified for free sale by the Ministry of Health at Lebanon.

Study Area:

The study will be performed in the gastroenterology clinic at National Guard Health Affairs(NGHA). Volunteers who participate in the study will be recruited from NGHA clinics. Participates are patients diagnosed with gastritis, both H. Pylori and non-H.Pylori infected, together with healthy volunteers.

The histological studies will be performed at the pathology department at NGHA.

Taking biopsies during endoscopy:

The best way to get tissue samples from the stomach is through a procedure called an esophagogastroduodenoscopy. It is more commonly known as an endoscopy or EGD. This is generally done as an outpatient procedure. The biopsies will be taken through the esophagogastroduodenoscopy (EGD) by a ultra-thin forceps, then will be saved in special container and send to the Laboratory for staining and microscopic examination. Under the microscope the pathologist will look for the abnormal mucosa , inflammation, ulceration , and helicobacter pylori gram negative micro-organism .During the procedure there is low chance of some complications which happened in 1: 10 000 , these include ; injury to the mucosa with bleeding and perforation , discomfort , sedation related complication like headache and nausea . These rare but the patient will be informed about it.

Study Subjects:

Patients with gastritis or showing gastritis symptoms will be enrolled in this study. Gastritis participate patients will be selected after detection of gastric lesions by undergoing routine diagnostic tests (such as endoscopy of upper digestive system).

Sample Size Calculation and Estimation:

The sample size has been estimated as 132 ( 22 subjects per group). The calculation and estimation have been done as follows:

Sample Size Calculation

The calculation of sample size was performed using Query Advisor V.7

Sample Size Estimated

The minimum number of Subjects needed in each group is 18, a two sided 95.0% confidence interval for the difference between a Group 1 proportion of 0.6 and Group 2 proportion of 0.2 based on the large sample normal approximation will extend 0.3 from the observed differences in proportions. The total required sample would be (6 groups x 18=108).The assumed withdrawal/dropout rate is 20% in each group (22 subjects per group), the final sample size would ne 132 subjects. The calculation of sample size was performed using Query Advisor V.7)

Data Collection method:

All data will be collected electronically and reported in Case Report Forms.

Data Cleaning:

Raw data will be processed in accordance with the best practices for raw data management to identify any inaccuracies or incompleteness in advance to the statistical analysis. In order to accomplish this task, all interval variables will be checked and summarized in terms of maximum and minimum values. Minimum and maximum values will be checked and compared against the nominal maximum and minimum value of each variable and variables with implausible values will be flagged. A similar process will be applied to categorical variables to identify any potential anomalies (miscode) by running a general frequency analysis.

Cohort Characterization:

All variables will be summarized and reported using descriptive statistics. Interval variables will be summarized and reported in terms of mean and standard deviation. Categorical variables will be summarized and reported in terms of frequency distribution. All variables will be compared across study groups using chi square and t test accordingly.

Primary Outcome(s) Analysis:

Chi square test will be used to compare the distribution of gastritis across the study groups. Results will be reported in terms of count, percent, and p-value. Significance will be declared at alfa less than 0.05. Binary logistic regression will be used to identify significant predictors of the primary outcomes. The statistical model will include key variables that showed significance with the primary outcome at the bivariate level. Results will be reported in terms of odds ratio, std. error, 95% confidence interval, and p-value. Significance will be declared at alfa less than 0.05.

Intent to treat analysis will be the approach in analyzing the data.

Statistical Analytical System(SAS) 9.2 will be used for all statistical analyses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Herbal Melanin
Herbal melanin 1800 milligram(mg) orally thrice a day with meals (300mgx2 capsules)
Other: Herbal Melanin
Herbal melanin extracted from Nigella sativa seeds
Other Names:
  • Melanole
Active Comparator: Nexium
omeprazole 40 mg once per day for one month.
Drug: Nexium
omeprazole
Other Names:
  • Aciloc
Experimental: H-Pylori infected : Herbal Melanin
Herbal melanin 1800 mg orally thrice a day(TID) with meals (300 mg x2 capsules)
Other: Herbal Melanin
Herbal melanin extracted from Nigella sativa seeds
Other Names:
  • Melanole
Active Comparator: nexium+ amoxil+clarithromycin

omeprazole40 mg P.O. Twice per Day(BID) for one month + Amoxil 1000mg P.O. BID for 2 weeks+ Clarithromycin500 mg PO BID for two weeks.

Omeprazole+Amoxil+clarithromycin is the standard triple therapy given
Drug: Nexium
omeprazole
Other Names:
  • Aciloc
Drug: Amoxil
Antibiotic
Drug: Clarithromycin
Antibiotic
Other Names:
  • Klacid
Experimental: nexium +Herbal melanin
omeprazole 40 mg P.O. BID for one month +1800 mg Herbal melanin PO TID (300mg x2 capsules) Omeprazole + Herbal melanin will be tested
Other: Herbal Melanin
Herbal melanin extracted from Nigella sativa seeds
Other Names:
  • Melanole
Drug: Nexium
omeprazole
Other Names:
  • Aciloc
Experimental: Herbal melanin+amoxil+ clarithromycin
Amoxil 1000mg P.O. BID for 2 weeks+ Clarithromycin500 mg PO BID for two weeks +1800 mg Herbal melanin PO TID(300 mg X 2 capsules) Herbal melanin+Amoxil+Clarithromycin will be tested
Other: Herbal Melanin
Herbal melanin extracted from Nigella sativa seeds
Other Names:
  • Melanole
Drug: Amoxil
Antibiotic
Drug: Clarithromycin
Antibiotic
Other Names:
  • Klacid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants cured from acidity symptoms and H.Pylori -induced gastritis
Time Frame: 6 months
Investigators hypothesize that HM is an effective candidate that can decrease stomach acidity and eradicate H.Pylori by working as Proton Pump Inhibitor(PPI) and/or antibacterial agent, respectively. Investigators suggest the role of HM in activation of Toll like Receptor 4 (TLR4)/Cycloxygenase2(COX2)/ProstaglandinE2( PGE2) as one underlying mechanism.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants cured with herbal melanin as compared to number of participants cured with standard of care for gastritis and H.Pylori-induced gastritis
Time Frame: 6 months
Gastritis as indicated by improving the clinical presentation of gastritis and confirmed by end of treatment endoscopy and stool antigen test
6 months
Number of Participants between study groups having high expression of TLR4 and COX2 as assessed by Western blots procedure.
Time Frame: 6 months
By using stomach biopsies for measuring the expression of TLR4 and COX 2 expression.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Abdullah International Medical Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adila SA Elobeid, PhD, Ministry of National Guard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC15/152/R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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