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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive arm | Placebo Comparator | Participants in this arm, who fit the inclusion criteria and have a GERD Q score of 3 or more, will be randomized to receive either Melanole, a herbal derived melanin, 300 mg, 2 capsules three times a day or placebo for 10 days.To assess the symptomatic improvement, GERD Q score will be calculated on day 0 (before administration of the product) and then on days 11 and 30 having taken the product for 10 days. |
|
| Invasive arm | Placebo Comparator | Participants in this arm will undergo a 24-hour pH monitoring before administration of Melanole, the herbal melanin or placebo. They will then be randomized to receive either Melanole or placebo for 10 days. pH metry will be repeated between days 7 and 10 from the study product or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melanole for GERD treatment | Dietary Supplement | Melanole is given orally as 2 capsules TID 5 minutes before each meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of GERD Q scores from baseline at day 11 as measured by the GERD Q questionnaire | GERD Q scores on day 0 and day 11 were compared and the difference was analyzed | GERD Q questionnaire and score were measured at day 0, then remeasured on day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Number of reflux episodes and total number of time where the pH in esophagus was less than 4 were calculated on days 0 and 11, and then analyzed to check how the given treatment affects the results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajaa Chatila, MD | Contact | 009613539849 | rajaa.chatila@lau.edu.lb | |
| Mohamad Mroueh, PhD | Contact | 009613298209 | mmroueh@lau.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Rajaa Chatila, MD | Lebanese American University | Principal Investigator |
| Hani Dimassi, PhD | Lebanese American University | Principal Investigator |
| Mohamad Mroueh, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lebanese American University | Recruiting | Beirut | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23735914 | Background | Spiegel B. Diagnostic testing in extraesophageal GERD: another case of "furor medicus"? Am J Gastroenterol. 2013 Jun;108(6):912-4. doi: 10.1038/ajg.2013.80. | |
| 23051678 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 9, 2019 | |
| Reset | Oct 31, 2019 | |
| Release | Oct 15, 2023 | |
| Reset | Apr 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 9, 2019 | Oct 31, 2019 | |||
| Oct 15, 2023 |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000723271 | Nigella sativa oil |
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| Placebo | Dietary Supplement | Placebo is given orally as 2 capsules TID 5 minutes before each meal |
|
| 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 |
| Lebanese American University |
| Principal Investigator |
| Lebanese American University | Recruiting | Byblos | Lebanon |
|
| 15831922 | Background | 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. |
| 19737151 | Background | 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. |
| 23646296 | Background | 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. |
| 19568521 | Background | 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. |
| Apr 5, 2024 |
| D004066 | Digestive System Diseases |