Functional dyspepsia
Conditions
Interventions
Chaihu Shugan San Treatment Group:Orally given Chaihu Shugan powder granules
Healthy People Group:None
Spleen deficiency and qi stagnation syndrome group:None
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meet the Western medical diagnostic criteria of Rome IV functional dyspepsia; 2.Meet the TCM diagnostic criteria for functional dyspepsia and liver-stomach discord; 3.Aged 18~65 years, no gender limit, outpatient; 4.Gastroscopy, B-ultrasound, CT examination, etc. have been performed within 6 months before selection to exclude related organic, systemic and metabolic diseases; 5.Carbon 13 or Carbon 14 breath test or endoscopic pathological test for Helicobacter pylori negative within 6 months before enrollment, or negative after treatment, 13C or 14C breath test should be performed within 6 months before enrollment; 6.The subjects gave informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria for healthy people 1. Those with abnormal laboratory test results at screening and judged to be clinically significant by the investigator; 2. Those who cannot tolerate venipuncture, have a history of fainting needle or blood sickness; 3. HBsAg positive, HCV-Ab positive, HIV-Ab positive or Tp-Ab positive; 4. Donated = 500 mL of blood within 4 weeks prior to screening, or had severe blood loss equivalent to at least 500 mL, or received blood transfusion within 8 weeks; 5. Have used any prescription drugs within 4 weeks before screening, including common drugs such as antibiotics and Chinese herbal medicines, and used over-the-counter drugs or food supplements, such as vitamins and calcium supplements, except for paracetamol up to 1000 mg per day, ibuprofen up to 2400 mg per day and topical over-the-counter preparations within 2 weeks; 6. Participated in the clinical trial of any drug or medical device within 3 months before screening; 7. Volunteers who, in the opinion of the investigator, have any factors that are not suitable for participating in this trial. Exclusion criteria for patients with FD 1. The differentiation is unclear or there are too many miscellaneous evidence; 2. Have taken drugs that interfere with this study within 2w before treatment, such as gastrointestinal promotility, anti-gastric acid secretion and other gastrointestinal related drugs; 3. Those with allergies or allergies to a variety of drugs, and those who are allergic to Bupleurum Shugansan and its components; 4. Those with a history of abdominal surgery; 5. Patients with overlap syndrome combined with gastroesophageal reflux and irritable bowel syndrome; 6. Patients with connective tissue diseases, endocrine and metabolic diseases such as diabetes, and menopausal syndrome; Those with serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival; 7. Suspected or definite history of drug and alcohol abuse; 8. Acupuncture, massage, cupping, auricular acupoints and other non-drug treatments; 9. Those with severe psychological disorders, mental illnesses or severe neuroses; Patients with cognitive-language impairment; 10. Patients who are pregnant, lactating or planning to become pregnant; 11. Persons with disabilities as prescribed by law (blind, deaf, mute, intellectually disabled, physically disabled); 12. According to the judgment of the investigator, other circumstances that reduce the likelihood of enrollment or complicate enrollment, such as frequent business trips, frequent changes in working environment and residence, which are easy to cause loss to follow-up; 13. Those who have received clinical trials of other drugs in the past 3 months; 14. Those who are considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum metabolomics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alanine aminotransferase (ALT); | — |
Countries
China
Contacts
Public ContactLing Jianghong
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed