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Clinical Efficacy Evaluation of Chaizhi Hewei Decoction in the Treatment of Non-Erosive Reflux Disease With Liver-Stomach Disharmony Syndrome
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Summary
This study focuses on patients with NERD (gastroesophageal reflux disease) and liver-gallbladder disharmony syndrome as its research subjects. It conducts a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the Chai Zhi He Wei formula in terms of symptom improvement, quality of life, and adverse reactions. On one hand, this research aims to enhance the level of evidence-based medicine for TCM syndrome differentiation and treatment of NERD. On the other hand, it seeks to reduce the dosage of PPIs (proton pump inhibitors) or discontinue their use, addressing the side effects caused by PPI overuse, and serving as a leading example for TCM clinical research. Lastly, the study aims to optimize the efficacy of Tongjiang granules and address potential safety concerns, such as diarrhea.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-05-15
Completion Date
2028-08-31
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Chaizhi Hewei Decoction
Chaizhi Hewei Decoction Granules, 1 packet per dose, twice daily, take 1 hour after breakfast and dinner, course duration: 4 weeks.
Placebo
Placebo, 1 packet per dose, twice daily, to be taken 1 hour after breakfast and dinner, with a course duration of 4 weeks.
Locations (1)
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China