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

Primary Purpose

GERD

Status
Unknown status
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
Melanole for GERD treatment
Placebo
Sponsored by
Lebanese American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GERD

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lebanese American UniversityRecruiting
  • Lebanese American UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

Non-invasive arm

Invasive arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Number of participants with treatment-related adverse events as reported during follow-up on days 3, 6 and 11.

Full Information

First Posted
October 17, 2015
Last Updated
October 26, 2015
Sponsor
Lebanese American University
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1. Study Identification

Unique Protocol Identification Number
NCT02587910
Brief Title
Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease
Acronym
GERDMeDS
Official Title
Melanole, a Nigella Sativa (Black Seed) Extract for the Treatment of Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lebanese American University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-invasive arm
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Invasive arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melanole for GERD treatment
Other Intervention Name(s)
GERDMeDS, Melanole, Nigella sativa
Intervention Description
Melanole is given orally as 2 capsules TID 5 minutes before each meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo is given orally as 2 capsules TID 5 minutes before each meal
Primary Outcome Measure Information:
Title
Change of GERD Q scores from baseline at day 11 as measured by the GERD Q questionnaire
Description
GERD Q scores on day 0 and day 11 were compared and the difference was analyzed
Time Frame
GERD Q questionnaire and score were measured at day 0, then remeasured on day 11
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
The pH metry study was conducted at day 0 ,and then reconducted on day 11
Title
Number of participants with treatment-related adverse events as reported during follow-up on days 3, 6 and 11.
Time Frame
Adverse events were recorded on days 3, 6 and 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajaa Chatila, MD
Phone
009613539849
Email
rajaa.chatila@lau.edu.lb
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamad Mroueh, PhD
Phone
009613298209
Email
mmroueh@lau.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajaa Chatila, MD
Organizational Affiliation
Lebanese American University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hani Dimassi, PhD
Organizational Affiliation
Lebanese American University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamad Mroueh, PhD
Organizational Affiliation
Lebanese American University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lebanese American University
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajaa Chatila, MD
Phone
009613539849
Email
rajaa.chatila@lau.edu.lb
Facility Name
Lebanese American University
City
Byblos
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajaa Chatila, MD
Phone
009613539849
Email
rajaa.chatila@lau.edu.lb
First Name & Middle Initial & Last Name & Degree
Mohamad Mroueh, PhD
Phone
009613298209
Email
mmroueh@lau.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
23735914
Citation
Spiegel B. Diagnostic testing in extraesophageal GERD: another case of "furor medicus"? Am J Gastroenterol. 2013 Jun;108(6):912-4. doi: 10.1038/ajg.2013.80. Erratum In: Am J Gastroenterol. 2013 Oct;108(10):1672.
Results Reference
background
PubMed Identifier
23051678
Citation
Magdy MA, Hanan el-A, Nabila el-M. Thymoquinone: Novel gastroprotective mechanisms. Eur J Pharmacol. 2012 Dec 15;697(1-3):126-31. doi: 10.1016/j.ejphar.2012.09.042. Epub 2012 Oct 7.
Results Reference
background
PubMed Identifier
15831922
Citation
Dent J, El-Serag HB, Wallander MA, Johansson S. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2005 May;54(5):710-7. doi: 10.1136/gut.2004.051821.
Results Reference
background
PubMed Identifier
19737151
Citation
Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.
Results Reference
background
PubMed Identifier
23646296
Citation
Ahmad A, Husain A, Mujeeb M, Khan SA, Najmi AK, Siddique NA, Damanhouri ZA, Anwar F. A review on therapeutic potential of Nigella sativa: A miracle herb. Asian Pac J Trop Biomed. 2013 May;3(5):337-52. doi: 10.1016/S2221-1691(13)60075-1.
Results Reference
background
PubMed Identifier
19568521
Citation
Al Mofleh IA, Alhaider AA, Mossa JS, Al-Sohaibani MO, Al-Yahya MA, Rafatullah S, Shaik SA. Gastroprotective effect of an aqueous suspension of black cumin Nigella sativa on necrotizing agents-induced gastric injury in experimental animals. Saudi J Gastroenterol. 2008 Jul;14(3):128-34. doi: 10.4103/1319-3767.41731.
Results Reference
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Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease

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