Efficacy and Safety of Hou Gu Mi Xi Rice Paste on Improving the Symptoms of Functional Dyspepsia: A Randomized, Placebo-Controlled, Clinical Trial

Beijing Shijitan Hospital0 个研究点目标入组 64 人开始时间: 2022年7月6日最近更新: 2024年3月18日

适应症

试验速览

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38455174/ (added 08/03/2024)

•1. Aged 18 to 80 years old with no gender restrictions
•2. Meet the diagnostic criteria for functional dyspepsia in Rome III (the absence of organic dyspepsia confirmed by endoscope)
•3. Normal gastroscopy results in the past 1 year, and no other organic lesions in the gastrointestinal tract
•4. No mental illness (Mini Mental State Questionnaire, MMSE = 20)
•5. Able to take food orally
•6. Volunteered to accept intervention and signed the informed consent
•7. Compliance with treatment completion and follow-up

•1. Severe cognitive impairment
•2. Abnormal electrocardiogram
•3. Organic digestive tract disease
•4. History of gastrointestinal surgery
•5. Diabetes
•6. Malignant tumors
•7. Other diseases
•8. Taking traditional Chinese medicine preparations
•9. Pregnancy and breast-feeding or planning to become pregnant within 6 months
•10. History of allergic reactions related to Chinese medicine or rice paste
•11. Impairment of liver and kidney function:
•11.1 Total bilirubin, alanine aminotransferase or aspartate aminotransferase> 2 times the upper limit of normal
•11.2. Serum creatinine> 2 times the upper limit of normal
•12. Drugs that affect digestive function taken within the past month and during the study period:
•12.1. Gastrointestinal motility drugs
•12.2. Anti-Helicobacter pylori drugs
•12.3. Antidepressants
•12.4. Antianxiety drugs
•12.5. Acid-suppressing drugs (PPIs and H2 receptor blockers)
•13. A place of residence that is too far, unwilling or unable to complete the return visit
•14. H. pylori positive by Carbon-13 urea breath test at the time of screening.

发起方

Beijing Shijitan Hospital