drugset / Trial / NCT03428568
Safety Trial of Herbal Melanin in Gastritis Patients
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-03
- Primary completion
- 2019-03
- Completion
- 2020-03
Publications
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- Background 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
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- Background 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.
- Background Mimura T, Maeda K, Tsujibo H, Satake M, Fujita T. Studies on biological activities of melanin from marine animals. II. Purification of melanin from Octopus vulgaris Cuvier and its inhibitory activity on gastric juice secretion in rats. Chem Pharm Bull (Tokyo). 1982 Apr;30(4):1508-12. doi: 10.1248/cpb.30.1508. No abstract available.
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- Background Schmausser B, Andrulis M, Endrich S, Muller-Hermelink HK, Eck M. Toll-like receptors TLR4, TLR5 and TLR9 on gastric carcinoma cells: an implication for interaction with Helicobacter pylori. Int J Med Microbiol. 2005 Jun;295(3):179-85. doi: 10.1016/j.ijmm.2005.02.009.
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- Background El-Obeid A, Hassib A, Ponten F, Westermark B. Effect of herbal melanin on IL-8: a possible role of Toll-like receptor 4 (TLR4). Biochem Biophys Res Commun. 2006 Jun 16;344(4):1200-6. doi: 10.1016/j.bbrc.2006.04.035. Epub 2006 May 2.
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- Background Zheng L, Riehl TE, Stenson WF. Regulation of colonic epithelial repair in mice by Toll-like receptors and hyaluronic acid. Gastroenterology. 2009 Dec;137(6):2041-51. doi: 10.1053/j.gastro.2009.08.055. Epub 2009 Sep 2.
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- Background Ohara T, Morishita T, Suzuki H, Masaoka T, Nagata H, Hibi T. Pathophysiological role of human beta-defensins 2 in gastric mucosa. Int J Mol Med. 2004 Dec;14(6):1023-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Subject | Clarithromycin | Small molecule | 500 mg | Oral |
| Subject | Herbal Melanin | Unknown | 1800 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 40 mg | Oral |