Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2013-06-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Supplement + Expanded Interview
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Expanded Interview
Placebo + Standard Interview
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo
Lactose tablets
Standard Interview
Supplement + Standard Interview
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Standard Interview
Placebo + Expanded Interview
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo
Lactose tablets
Expanded Interview
Interventions
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Supplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Placebo
Lactose tablets
Expanded Interview
Standard Interview
Eligibility Criteria
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Inclusion Criteria
* Fluency in written and spoken English.
* Heartburn symptoms 3 or more days per week for the past month.
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Gloria Y. Yeh
Associate Professor of Medicine
Principal Investigators
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Michelle Dossett, MD, PhD, MPH
Role: STUDY_DIRECTOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Dossett ML, Mu L, Davis RB, Bell IR, Lembo AJ, Kaptchuk TJ, Yeh GY. Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial. PLoS One. 2015 Sep 30;10(9):e0136855. doi: 10.1371/journal.pone.0136855. eCollection 2015.
Related Links
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Other Identifiers
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IND 117358
Identifier Type: OTHER
Identifier Source: secondary_id
2012P000409
Identifier Type: -
Identifier Source: org_study_id
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