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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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GERD

Intervention / Treatment
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* Dietary Supplement: Melanole for GERD treatment
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-invasive arm<br>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<br>* Melanole is given orally as 2 capsules TID 5 minutes before each meal<br>* Other names: Nigella sativa;Dietary Supplement: Placebo<br>* Placebo is given orally as 2 capsules TID 5 minutes before each meal<br>|
| Placebo Comparator: Invasive arm<br>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<br>* Melanole is given orally as 2 capsules TID 5 minutes before each meal<br>* Other names: Nigella sativa;Dietary Supplement: Placebo<br>* Placebo is given orally as 2 capsules TID 5 minutes before each meal<br>|

What is the study measuring?
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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 |