Melanole, a Nigella Sativa (Black Seed) Extract for the Treatment of Gastroesophageal Reflux Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Change of GERD Q scores from baseline at day 11 as measured by the GERD Q questionnaire
研究概览
简要总结
Melanole, a Nigella sativa (Black Seed) extract , is studied for the treatment of GERD. Participants, who meet the inclusion criteria, will be divided into two arms.
Arm 1: Subjects who meet criteria for GERD will undergo 24 hour pH monitoring.
Arm 2: Subjects who meet criteria for GERD and who undergo only symptomatic monitoring of GERD on treatment.
All participants will be evaluated before and after the administration of the study product.
详细描述
Volunteers were recruited in Lebanese American University campuses. Those who fit the inclusion criteria were allowed to choose between two arms: invasive or non-invasive procedures.
Volunteers who chose to enroll in the non-invasive arm were given the study product directly after completing the GERD Q questionnaire. A follow-up by phone was done on day 0, 3 , 6 and 11. GERD Q questionnaire was repeated on days 11 and 28 along with a satisfaction rating. Adverse events were reported on a log sheet.
Concerning the invasive arm, volunteers were given an appointment at Lebanese American University Medical Center Rizk Hospital to place the 24h pH-metry, after study product was administered. After 7-10 days, the 24h pH monitoring was done again.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Adult patients with age (18-60) with GerdQ score ≥3
排除标准
- •Patients younger than 18 year or older than 60years
- •Dysphagia, odynophagia, weight loss, palpable mass
- •Nonsteroidal antiinflammatory drug intake (including aspirin)
- •History of hyperparathyroidism
- •Coronary artery disease or congestive heart failure
- •History of liver disease
- •History of renal disease
- •Pregnancy
- •History of active cancer or chemotherapy
- •History of intake of any drug known to affect reflux (phenothiazine, anticholinergic, nitrates, calcium channel blockers and proton pump inhibitors) within 14 days of inclusion to the study
- •Prior esophageal or gastric surgeries of any type
- •Allergy to black seeds or Lidocaine
- •Any important nasal anatomical anomaly
- •Any use of chronic medications for chronic medical conditions
结局指标
主要结局
Change of GERD Q scores from baseline at day 11 as measured by the GERD Q questionnaire
时间窗: GERD Q questionnaire and score were measured at day 0, then remeasured on day 11
GERD Q scores on day 0 and day 11 were compared and the difference was analyzed
次要结局
- Number of patients experiencing a reduction in the number of reflux episodes by 10 or more where the reflux episode is defined as a pH reading less than 4, as well was a reduction in the total time where the pH in esophagus is less than 4.(The pH metry study was conducted at day 0 ,and then reconducted on day 11)
- Number of participants with treatment-related adverse events as reported during follow-up on days 3, 6 and 11.(Adverse events were recorded on days 3, 6 and 11)
研究者
Dr Rajaa Chatila
Associate Professor of Medicine
Lebanese American University