Efficacy and safety of Hou Gu Mi Xi rice paste on improving the symptoms of indigestio
- Conditions
- Functional dyspepsiaDigestive System
- Registration Number
- ISRCTN17174559
- Lead Sponsor
- Beijing Shijitan Hospital
- Brief Summary
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38455174/ (added 08/03/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall severity of dyspepsia symptoms measured using the 7-point global overall symptom scale (GOSS) at baseline (0 day), 15th, 30th, and 60th days after treatment, and follow-up at 1 month after the expiration of the intervention
- Secondary Outcome Measures
Name Time Method Quality-of-life, adverse reactions and other indicators measured using the 36-Item Short Form Survey (SF-36) at baseline (0 day), 15th, 30th, and 60th days after treatment, and follow-up at 1 month after the expiration of the intervention