NCT02587910

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

October 17, 2015

Last Update Submit

October 26, 2015

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 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

Study Arms (2)

Non-invasive arm

PLACEBO COMPARATOR

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 treatmentDietary Supplement: Placebo

Invasive arm

PLACEBO COMPARATOR

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 treatmentDietary Supplement: Placebo

Interventions

Melanole for GERD treatmentDIETARY_SUPPLEMENT

Melanole is given orally as 2 capsules TID 5 minutes before each meal

Also known as: GERDMeDS, Melanole, Nigella sativa
Invasive armNon-invasive arm
PlaceboDIETARY_SUPPLEMENT

Placebo is given orally as 2 capsules TID 5 minutes before each meal

Invasive armNon-invasive arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lebanese American University

Beirut, Lebanon

RECRUITING

Lebanese American University

Byblos, Lebanon

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23735914BACKGROUND

  • 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.

    PMID: 23051678BACKGROUND

  • 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.

    PMID: 15831922BACKGROUND

  • 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.

    PMID: 19737151BACKGROUND

  • 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.

    PMID: 23646296BACKGROUND

  • 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.

    PMID: 19568521BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Rajaa Chatila, MD

    Lebanese American University

    PRINCIPAL INVESTIGATOR

  • Hani Dimassi, PhD

    Lebanese American University

    PRINCIPAL INVESTIGATOR

  • Mohamad Mroueh, PhD

    Lebanese American University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajaa Chatila, MD

CONTACT

009613539849rajaa.chatila@lau.edu.lb

Mohamad Mroueh, PhD

CONTACT

009613298209mmroueh@lau.edu.lb

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

October 17, 2015

First Posted

October 27, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

September 1, 2016

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

LE(2)