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Safety Trial of Herbal Melanin in Gastritis Patients (RASATHEME)

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ClinicalTrials.gov Identifier: NCT03428568
Recruitment Status : Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

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.


Condition or disease Intervention/treatment Phase
Acid Dyspepsia Gastritis Other: Herbal Melanin Drug: Nexium Drug: Amoxil Drug: Clarithromycin Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
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 Name: Melanole

Active Comparator: Nexium
omeprazole 40 mg once per day for one month.
Drug: Nexium
omeprazole
Other Name: 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 Name: 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 Name: Aciloc

Drug: Amoxil
Antibiotic

Drug: Clarithromycin
Antibiotic
Other Name: 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 Name: Melanole

Drug: Nexium
omeprazole
Other Name: 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 Name: Melanole

Drug: Amoxil
Antibiotic

Drug: Clarithromycin
Antibiotic
Other Name: Klacid




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428568


Contacts
Contact: Adila SA Elobeid, PhD +966553543096 adilasalihelobeid@gmail.com
Contact: khizra sultana, Masters +966542403883 khizzy31@gmail.com

Sponsors and Collaborators
King Abdullah International Medical Research Center
Investigators
Principal Investigator: Adila SA Elobeid, PhD Ministry of National Guard

Publications:
Biotechnological Method for Production of Melanin Pigments. Patent, award by Swedish PRV Patent office-Stockholm 2011 and United Nations PCT-WIPO 2011. Registered in US &Canada
Extraction of melanin from Nigella sativa L. Patent No. 451, Khartoum, Sudan. 1998.
Tortora, G.J. and Grabowski, S.R. (2003). Principles of Anatomy and Physiology. 10th ed. John Wiley& Sons, Inc, NJ, p.889.).
El-Tahir, K. E. H.; Hassib, A. M.; El-Hag, H.; Ponten, F.; Westermark, B. El- Obeid Adila (2009). Anti-ulcerogenic effects of Nigella sativa Melanin. Sudan Patent No. 1683.
Hoogerwerf et al. 2006. Hoogerwerf, W.J., Pasricha, P.J., 2006. Pharmacotherapy of gastric acidity,peptic ulcer and gastroesophageal reflux disease: Goodman and Gilman's.The pharmacological basis of therapeutics. McGraw-Hill, United States, pp.869-882).

Responsible Party: King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT03428568     History of Changes
Other Study ID Numbers: RC15/152/R
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King Abdullah International Medical Research Center:
Herbal Melanin
H.Pylori

Additional relevant MeSH terms:
Omeprazole
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Clarithromycin
Amoxicillin
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors