Clinical trial NCT02587910: Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease
Official title: Melanole, a Nigella Sativa (Black Seed) Extract for the Treatment of Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: GERD
Lead sponsor: Lebanese American University
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients with age (18-60) with GerdQ score ≥3

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of GERD Q scores from baseline at day 11 as measured by the GERD Q questionnaire
timeFrame: GERD Q questionnaire and score were measured at day 0, then remeasured on day 11
Secondary outcomes:
measure: 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.
timeFrame: The pH metry study was conducted at day 0 ,and then reconducted on day 11
measure: Number of participants with treatment-related adverse events as reported during follow-up on days 3, 6 and 11.
timeFrame: Adverse events were recorded on days 3, 6 and 11
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Lebanese American University
city: Byblos
country: Lebanon
facility: Lebanese American University
Study officials:
affiliation: Lebanese American University
name: Rajaa Chatila, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lebanese American University
name: Hani Dimassi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lebanese American University
name: Mohamad Mroueh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Magdy MA, Hanan el-A, Nabila el-M. Thymoquinone: Novel gastroprotective mechanisms. Eur J Pharmacol. 2012 Dec 15;697(1-3):126-31. doi: 10.1016/j.ejphar.2012.09.042. Epub 2012 Oct 7.
citation: Dent J, El-Serag HB, Wallander MA, Johansson S. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2005 May;54(5):710-7. doi: 10.1136/gut.2004.051821.
citation: Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.
citation: Ahmad A, Husain A, Mujeeb M, Khan SA, Najmi AK, Siddique NA, Damanhouri ZA, Anwar F. A review on therapeutic potential of Nigella sativa: A miracle herb. Asian Pac J Trop Biomed. 2013 May;3(5):337-52. doi: 10.1016/S2221-1691(13)60075-1.
citation: Al Mofleh IA, Alhaider AA, Mossa JS, Al-Sohaibani MO, Al-Yahya MA, Rafatullah S, Shaik SA. Gastroprotective effect of an aqueous suspension of black cumin Nigella sativa on necrotizing agents-induced gastric injury in experimental animals. Saudi J Gastroenterol. 2008 Jul;14(3):128-34. doi: 10.4103/1319-3767.41731.