GERD Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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