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OpenTrials
Completed

NCT Number: NCT01915173

Response to Supplement and Placebo in GERD

The purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (GERD). This study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Dyspepsia Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult humans age 18-80.
  • Fluency in written and spoken English.
  • Heartburn symptoms 3 or more days per week for the past month.

Exclusion criteria

  • Individuals taking a proton pump inhibitor (PPI) or H2 receptor blocker with a dose change within 2 weeks of the initial study visit.
  • Individuals with Crohns disease, systemic sclerosis, known active ulcer disease, gastric cancer, Barrett's esophagitis
  • Significant pain or difficulty with swallowing
  • Heavy alcohol use (defined by > 6 drinks/week for women and > 13 drinks/week for men)
  • Concurrent pregnancy
  • Dementia
  • Uncontrolled psychiatric disease
  • Individuals unable to complete a paper symptom diary for 6 of 7 days prior to their baseline visit
  • Subjects whose symptoms are predominantly dyspeptic more than heartburn or reflux
  • Subjects who have used homeopathy for GI symptoms or have received constitutional homeopathic treatment within the past 2 weeks
  • Subjects taking herbal products or other supplements for GERD or dyspepsia related symptoms (includes peppermint oil)
  • Subjects who have taken > 12 doses of NSAIDS within the prior 30 days (aspirin ≤ 325 mg daily is allowed)
  • Subjects with lactose intolerance

Treatment and study plan

supplement

Drug

Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C

Placebo

Drug

Lactose tablets

Expanded Interview

Behavioral

Standard Interview

Behavioral

Primary outcomes

  1. Safety - Number of Participants Experiencing a Serious Adverse Event

    Time frame: 2 week follow-up

    Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.

Secondary outcomes

  1. Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity

    Time frame: Second week of the trial compared to pre-trial baseline

    Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.

  2. GERD Health-Related Quality of Life at Follow-up

    Time frame: Two weeks

    The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2013
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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