Safety Trial of Herbal Melanin in Gastritis Patients

NCT03428568 | Unknown Phase 2

• 1 other identifier: RC15/152/R
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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.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.

Conditions

Acid Dyspepsia; Gastritis

Keywords

Herbal Melanin; H.Pylori

Outcome Measures

Primary Outcomes (1)

• Number of participants cured from acidity symptoms and H.Pylori -induced gastritis

  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 Outcomes (2)

• 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

  6 months

• Number of Participants between study groups having high expression of TLR4 and COX2 as assessed by Western blots procedure.

  6 months

Study Arms (6)

Herbal Melanin

EXPERIMENTAL

Herbal melanin 1800 milligram(mg) orally thrice a day with meals (300mgx2 capsules)

Other: Herbal Melanin

Nexium

ACTIVE COMPARATOR

omeprazole 40 mg once per day for one month.

Drug: Nexium

H-Pylori infected : Herbal Melanin

EXPERIMENTAL

Herbal melanin 1800 mg orally thrice a day(TID) with meals (300 mg x2 capsules)

Other: Herbal Melanin

nexium+ amoxil+clarithromycin

ACTIVE COMPARATOR

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; Drug: Amoxil; Drug: Clarithromycin

nexium +Herbal melanin

EXPERIMENTAL

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; Drug: Nexium

Herbal melanin+amoxil+ clarithromycin

EXPERIMENTAL

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; Drug: Amoxil; Drug: Clarithromycin

Interventions

Herbal Melanin OTHER

Herbal melanin extracted from Nigella sativa seeds

Also known as: Melanole

H-Pylori infected : Herbal Melanin; Herbal Melanin; Herbal melanin+amoxil+ clarithromycin; nexium +Herbal melanin

Nexium DRUG

omeprazole

Also known as: Aciloc

Nexium; nexium +Herbal melanin; nexium+ amoxil+clarithromycin

Amoxil DRUG

Antibiotic

Herbal melanin+amoxil+ clarithromycin; nexium+ amoxil+clarithromycin

Clarithromycin DRUG

Antibiotic

Also known as: Klacid

Herbal melanin+amoxil+ clarithromycin; nexium+ amoxil+clarithromycin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Related Publications (29)

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MeSH Terms

Conditions

Gastritis

Interventions

Esomeprazole; Amoxicillin; Clarithromycin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Adila SA Elobeid, PhD

  Ministry of National Guard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adila SA Elobeid, PhD

CONTACT

+966553543096; adilasalihelobeid@gmail.com

khizra sultana, Masters

CONTACT

+966542403883; khizzy31@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2018
• First Posted: February 9, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: February 9, 2018

Record last verified: 2017-12