Response to Supplement and Placebo in GERD
NCT01915173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2017-03-29
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.
Conditions
- Gastroesophageal Reflux Disease (GERD)
- Heartburn
- Dyspepsia
Interventions
- DRUG
-
Supplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
- DRUG
-
Lactose tablets
- BEHAVIORAL
-
Expanded Interview
- BEHAVIORAL
-
Standard Interview
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Michelle Dossett, MD, PhD, MPH · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2014-04-30
- Completion
- 2014-04-30
Countries
- United States
Study Locations
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