NCT02587910

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Lebanese American University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• GERD

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melanole for GERD treatment	Melanole is given orally as 2 capsules TID 5 minutes before each meal
DIETARY_SUPPLEMENT	Placebo	Placebo is given orally as 2 capsules TID 5 minutes before each meal

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-04-01
• Completion: 2016-09-01
• First posted: 2015-10-27
• Last updated: 2015-10-28

Locations

2 sites across 1 country: Lebanon