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
试验速览
- 阶段
- 2 期
- 入组人数
- 132
- 主要终点
- Number of participants cured from acidity symptoms and H.Pylori -induced gastritis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Herbal Melanin
Herbal melanin 1800 milligram(mg) orally thrice a day with meals (300mgx2 capsules)
干预措施: Herbal Melanin (Other)
Nexium
omeprazole 40 mg once per day for one month.
干预措施: Nexium (Drug)
H-Pylori infected : Herbal Melanin
Herbal melanin 1800 mg orally thrice a day(TID) with meals (300 mg x2 capsules)
干预措施: Herbal Melanin (Other)
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
干预措施: Nexium (Drug)
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
干预措施: Amoxil (Drug)
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
干预措施: Clarithromycin (Drug)
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
干预措施: Herbal Melanin (Other)
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
干预措施: Nexium (Drug)
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
干预措施: Herbal Melanin (Other)
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
干预措施: Amoxil (Drug)
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
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Number of participants cured from acidity symptoms and H.Pylori -induced gastritis
时间窗: 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.
次要结局
- Number of Participants between study groups having high expression of TLR4 and COX2 as assessed by Western blots procedure.(6 months)
- 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)