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

Phase 2

• Conditions: GERD
• Interventions: Dietary Supplement: Melanole for GERD treatment; Dietary Supplement: Placebo

• Registration Number: NCT02587910
• Lead Sponsor: Lebanese American University

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.

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-17
• Study First Submitted QC: 2015-10-23
• Last Update Submitted: 2015-10-26
• Study First Posted: 2015-10-27
• Last Update Posted: 2015-10-28
• Primary Completion: 2016-04
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Adult patients with age (18-60) with GerdQ score ≥3

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive arm	Melanole for GERD treatment	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.
Invasive arm	Placebo	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.
Non-invasive arm	Placebo	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.
Invasive arm	Melanole for GERD treatment	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lebanese American University; 🇱🇧 Byblos, Lebanon