GERD
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTMelanole for GERD treatment
Melanole is given orally as 2 capsules TID 5 minutes before each meal
DIETARY_SUPPLEMENTPlacebo
Placebo is given orally as 2 capsules TID 5 minutes before each meal
Sponsors
Lebanese American University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of GERD Q scores from baseline at day 11 as measured by the GERD Q questionnaire | GERD Q questionnaire and score were measured at day 0, then remeasured on day 11 | GERD Q scores on day 0 and day 11 were compared and the difference was analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | The pH metry study was conducted at day 0 ,and then reconducted on day 11 | 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 |
| 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 | — |
Countries
Lebanon
Contacts
Primary ContactRajaa Chatila, MD
Backup ContactMohamad Mroueh, PhD
Outcome results
None listed