Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease

GERD Clinical Trial

— GERDMeDS  

Official title:

Melanole, a Nigella Sativa (Black Seed) Extract for the Treatment of Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02587910
• Other study ID #: LAUMCRH.RC3.23/Sep/2015
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 17, 2015
• Last updated: October 26, 2015
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: Lebanese American University
• Contact: Rajaa Chatila, MD
• Phone: 009613539849
• Email: rajaa.chatila[@]lau.edu.lb
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Dietary Supplement:
• Melanole for GERD treatment
Melanole is given orally as 2 capsules TID 5 minutes before each meal
• Placebo
Placebo is given orally as 2 capsules TID 5 minutes before each meal

Locations

Country	Name	City	State
Lebanon	Lebanese American University	Beirut
Lebanon	Lebanese American University	Byblos

Sponsors (1)

Lead Sponsor	Collaborator
Lebanese American University

Country where clinical trial is conducted

Lebanon, 

References & Publications (6)

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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

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. Erratum in: Am J Gastroenterol. 2013 Oct;108(10):1672. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	The pH metry study was conducted at day 0 ,and then reconducted on day 11	No
Secondary	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	No