GERDPhase 2/3GERDMeDSNCT02587910
Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease
A Phase 2/3 study testing Melanole for GERD treatment in people with GERD, run by Lebanese American University at 2 sites in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- GERD
- What is being tested?
- Melanole for GERD treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 2 sitesLebanon
- Study dates
- Oct 2015to Sep 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients with age (18-60) with GerdQ score ≥3
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites, 2 recruiting
- Recruiting
Lebanese American University
Beirut
Rajaa Chatila, MD, 009613539849, rajaa.chatila@lau.edu.lb
- Recruiting
Lebanese American University
Byblos
Rajaa Chatila, MD, 009613539849, rajaa.chatila@lau.edu.lb
Mohamad Mroueh, PhD, 009613298209, mmroueh@lau.edu
About this study
Official title: Melanole, a Nigella Sativa (Black Seed) Extract for the Treatment of Gastroesophageal Reflux Disease
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.
Read the 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.
- Conditions
- GERD
- Being tested
- Melanole for GERD treatment, Placebo
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanole for GERD treatmentDietary supplement
Also called GERDMeDS, Melanole, Nigella sativa
Melanole is given orally as 2 capsules TID 5 minutes before each meal
PlaceboDietary supplement
Placebo is given orally as 2 capsules TID 5 minutes before each meal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Melanole for GERD treatment; Dietary 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. Receives: Dietary Supplement: Melanole for GERD treatment; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: 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.
Measured: Adverse events were recorded on days 3, 6 and 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Rajaa Chatila, Lebanese American University
- Investigators
- Rajaa Chatila, MD, Principal investigator, Lebanese American UniversityHani Dimassi, PhD, Principal investigator, Lebanese American UniversityMohamad Mroueh, PhD, Principal investigator, Lebanese American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587910
- Sponsor's protocol ID
- LAUMCRH.RC3.23/Sep/2015
- Acronym
- GERDMeDS
- Status last verified
- Oct 2015
- First submitted
- 17 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23735914Magdy 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.
PubMed 23051678Dent 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.
PubMed 15831922Jones 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.
PubMed 19737151Ahmad 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.
PubMed 23646296Al 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.
PubMed 19568521
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanole, a Nigella Sativa (Black Seed) Extract for the Treatment of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT02587910
- Acronym / sponsor ID
- GERDMeDS / LAUMCRH.RC3.23/Sep/2015
- Conditions
- GERD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive arm | Placebo comparator | Dietary Supplement: Melanole for GERD treatment, Dietary Supplement: PlaceboParticipants 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 comparator | Dietary Supplement: Melanole for GERD treatment, Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients with age (18-60) with GerdQ score ≥3
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melanole for GERD treatmentAlso: GERDMeDS, Melanole, Nigella sativaMelanole is given orally as 2 capsules TID 5 minutes before each meal | Dietary supplement | Invasive arm, Non-invasive arm |
| PlaceboPlacebo is given orally as 2 capsules TID 5 minutes before each meal | Dietary supplement | Invasive arm, Non-invasive arm |
Primary outcome
Change of GERD Q scores from baseline at day 11 as measured by the GERD Q questionnaire
Time frame: 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
2 secondary outcomes
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.
Time frame: 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.
Time frame: Adverse events were recorded on days 3, 6 and 11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Background: PubMed 23735914Spiegel 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.
- Background: PubMed 23051678Magdy 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.
- Background: PubMed 15831922Dent 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.
- Background: PubMed 19737151Jones 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.
- Background: PubMed 23646296Ahmad 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.
- Background: PubMed 19568521Al 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.
- Complications of gastroesophageal reflux in adultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajaa Chatila, MD principal investigator
Lebanese American University
Hani Dimassi, PhD principal investigator
Lebanese American University
Mohamad Mroueh, PhD principal investigator
Lebanese American University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melanole for GERD treatment in people with GERD, run by Lebanese American University at 2 sites in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rajaa Chatila, MD (009613539849, rajaa.chatila@lau.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of GERD Q scores from baseline at day 11 as measured by the GERD Q questionnaire (time frame: GERD Q questionnaire and score were measured at day 0, then remeasured on day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587910, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.