Response to Supplement and Placebo in GERD

Dyspepsia Clinical Trial

Official title:

Response to Supplement and Placebo in GERD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915173
• Other study ID #: 2012-P-000409
• Secondary ID: IND 117358
• Status: Completed
• Phase: N/A
• First received: July 30, 2013
• Last updated: May 28, 2014
• Start date: June 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)
• Heartburn

Intervention

Drug:
• Supplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
• Placebo
Lactose tablets

Behavioral:
• Expanded Interview

• Standard Interview

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - number of major and minor adverse events	No major adverse events (as defined by FDA criteria) attributed to the study intervention and no statistically significant increase in minor adverse events between the intervention and placebo arms.	2 week follow-up	Yes
Secondary	Percent of subjects with a 50% or greater decrease in heartburn symptom severity	Based on daily symptom diary scores.	Second week of the trial compared to pre-trial baseline	No
Secondary	Percent improvement in disease-specific and overall quality of life		Two weeks (baseline to follow-up)	No