Currently submitted to: JMIR Research Protocols
Date Submitted: Jul 25, 2026
Open Peer Review Period: Jul 27, 2026 - Sep 21, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effects of Three-Dimensional Acid-Suppressing Formula on acid reflux associated with gastroesophageal reflux disease: study protocol for a randomized, double-blind, double-dummy, placebo-controlled trial
ABSTRACT
Background:
Reflux is one of the primary symptoms of gastroesophageal reflux disease (GERD), with acid reflux being its predominant form. Proton pump inhibitors (PPIs) are the first-line treatment for GERD-related acid reflux, but they have limitations such as low efficacy rates and frequent adverse reactions.
Objective:
This study aims to evaluate the safety and efficacy of the Three-Dimensional Acid Suppression Formula in treating acid reflux associated with GERD characterized by a complex pattern of mixed cold-heat.
Methods:
This is a randomized, double-blind, double-dummy, placebo-controlled clinical trial requiring the recruitment of 82 eligible participants. Patients with GERD-related acid reflux meeting the criteria for the TCM pattern of “cold-heat mixed syndrome” will be randomly assigned in a 1:1 ratio to either the treatment group or the control group. The treatment group will receive the Three-Dimensional Acid-Suppressing Formula pill formulation combined with a placebo of omeprazole enteric-coated capsules. The control group will receive the placebo of the Three-Dimensional Acid-Suppressing Formula pill formulation combined with omeprazole enteric-coated capsules. Each group's treatment cycle will last four weeks. The primary outcome measure are the clinical symptom score and 24-hour oesophageal multichannel intraluminal impedance-pH monitoring. Secondary observation indicators are Gastro-oesophageal Reflux Disease Health-Related Quality of Life Questionnaire (GERD-HRQL), salivary pepsin assay, gastric function quadruple assessment, followed by safety and adverse reactions after treatment completion.
Results:
The study was approved by the the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM (Approval Number: 2025-246). Recruitment started in January 2026 and was scheduled for completion in January 2027. Database lock and primary analysis are planned for March 2027, and submission of the first results is expected in May 2027.
Conclusions:
This study will validate the efficacy of the Three-Dimensional Acid Suppression Formula in treating acid reflux associated with GERD characterized by mixed cold-heat pattern. The clinical efficacy of the Three-Dimensional Acid Suppression Formula is expected to surpass that of omeprazole enteric-coated capsules, thereby reducing patients' physical and psychological burdens and yielding significant social benefits. Clinical Trial: International Traditional Medicine Clinical Trial Registry ITMCTR2025002610; https://itmctr.ccebtcm.org.cn/mgt/project/view/2005907582434279424
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