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

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

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.

Study Overview

• Status: Unknown
• Conditions: GERD
• Intervention / Treatment: Dietary supplement: Melanole for GERD treatment; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Rajaa Chatila, MD; Phone Number: 009613539849; Email: rajaa.chatila@lau.edu.lb
• Study Contact Backup: Name: Mohamad Mroueh, PhD; Phone Number: 009613298209; Email: mmroueh@lau.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • Lebanese American University
    • Contact: Rajaa Chatila, MD; Phone Number: 009613539849; Email: rajaa.chatila@lau.edu.lb
  • Byblos, Lebanon
    • Recruiting
    • Lebanese American University
    • Contact: Rajaa Chatila, MD; Phone Number: 009613539849; Email: rajaa.chatila@lau.edu.lb
    • Contact: Mohamad Mroueh, PhD; Phone Number: 009613298209; Email: mmroueh@lau.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Non-invasive arm; 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.	Dietary supplement: Melanole for GERD treatment; Melanole is given orally as 2 capsules TID 5 minutes before each meal; Other Names: GERDMeDS; Melanole; Nigella sativa; Dietary supplement: Placebo; Placebo is given orally as 2 capsules TID 5 minutes before each meal
Placebo Comparator: Invasive arm; 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.	Dietary supplement: Melanole for GERD treatment; Melanole is given orally as 2 capsules TID 5 minutes before each meal; Other Names: GERDMeDS; Melanole; Nigella sativa; Dietary supplement: Placebo; Placebo is given orally as 2 capsules TID 5 minutes before each meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Lebanese American University
• Investigators: Principal Investigator: Rajaa Chatila, MD, Lebanese American University; Principal Investigator: Hani Dimassi, PhD, Lebanese American University; Principal Investigator: Mohamad Mroueh, PhD, Lebanese American University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Complications of gastroesophageal reflux in adults

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: October 17, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 26, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: LAUMCRH.RC3.23/Sep/2015