MedTrace Logo

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

NCT02587910 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2015-10-28

No results posted yet for this study

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.

Conditions

  • GERD

Interventions

DIETARY_SUPPLEMENT

Melanole for GERD treatment

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Lebanese American University

    lead OTHER

Principal Investigators

  • Rajaa Chatila, MD · Lebanese American University

  • Hani Dimassi, PhD · Lebanese American University

  • Mohamad Mroueh, PhD · Lebanese American University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-04-30
Completion
2016-09-30

Countries

  • Lebanon

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02587910 on ClinicalTrials.gov