Functional Dyspepsia
Conditions
Interventions
Experimental Group:Jinweitai Capsules, 0.3g per capsule, three times daily, three capsules each time, taken orally 30 minutes after meals, for a total course of 4 weeks.
Control Group:Jinweitai Capsule Placebo, 0.3g per capsule, three times daily, three capsules each time, taken orally 30 minutes after meals, for a total of 4 weeks.
Sponsors
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Fulfill the diagnostic criteria for functional dyspepsia. 2.Conform to the Traditional Chinese Medicine (TCM) syndrome differentiation criteria for spleen-stomach damp-heat pattern. 3.Be 18–65 years of age, with no gender restriction. 4.Score = 3 on the 5-point Likert scale for at least one primary symptom (postprandial fullness, early satiety, epigastric pain, or epigastric burning). 5.Provide written informed consent after being fully informed of the study protocol and voluntarily agreeing to participate.
Exclusion criteria
Exclusion criteria: 1.Patients with severe primary cardiac, cerebral, hepatic, pulmonary, renal, hematological, or other life-threatening diseases. 2.Abnormal hepatic or renal function; defined as: creatinine > 1.5 × upper limit of normal (ULN), and/or AST, ALT > 2.0 × ULN, and/or total bilirubin > 1.5 × ULN. 3.History of gastrointestinal surgery potentially related to dyspeptic symptoms. 4.Requirement for concomitant medication during the study or use of drugs that may affect efficacy assessment within 2 weeks prior to enrollment, such as antacids, prokinetics, anticholinergics, prostaglandin analogues, nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, anxiolytics, or antidepressants. 5.Known history of hypersensitivity to any component of the study drug. 6.Patients with psychiatric disorders or comorbid moderate-to-severe anxiety or depression (HAMA-14 = 14, HAMD-17 > 17). 7.Pregnant or lactating women, or patients planning pregnancy in the near future. 8.Patients with suspected or confirmed history of alcohol or drug abuse (alcohol abuse defined as: consumption of > 28 units of alcohol per week within the past 3 months; 1 unit = 285 mL beer / 25 mL spirits / 1 glass of wine). 9.Patients who participated in other clinical drug trials within the past 3 months. 10.Other conditions judged by the investigator that may reduce the likelihood of enrollment or complicate enrollment, such as patients with frequently changing work environments that may lead to loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Symptom Response Rate of Functional Dyspepsia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Effective Rate of TCM Syndrome;Individual symptom resolution rate;Individual symptom relief rate;Time to onset of individual symptom relief;Quality of Life Improvement Rate; | — |
Countries
China
Contacts
Public ContactLin Jiang
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed