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

Lebanese American University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: GERD

Treatments: Dietary Supplement: Melanole for GERD treatment; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02587910

LAUMCRH.RC3.23/Sep/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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170 participants in 2 patient groups, including a placebo group

Non-invasive arm

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Melanole for GERD treatment

Dietary Supplement: Placebo

Invasive arm

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Melanole for GERD treatment

Dietary Supplement: Placebo