The treatment of patients with functional dyspepsia Digestive System
Conditions
Interventions
The study adopted a multicenter, randomized, double-blind, placebo-parallel-controlled design, with stratification factors including study center and TCM syndrome type. The ratio of the treatment grou
Sponsors
Jiangxi Qingfeng Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form 2. Meet the Western medical diagnostic criteria for functional dyspepsia 3. Conform to the Traditional Chinese Medicine (TCM) syndrome diagnostic criteria for epigastric stuffiness (including liver-stomach disharmony, spleen-stomach damp-heat, and food stagnation syndromes) 4. Aged 18 to 65 years at the time of enrollment
Exclusion criteria
Exclusion criteria: 1. Individuals with organic diseases such as esophagitis, atrophic gastritis, gastric and duodenal ulcers, erosions, tumors, etc. 2. Individuals with organic diseases of the liver, gallbladder, or pancreas 3. Individuals with diabetes, kidney disease, connective tissue disease, or psychiatric disorders 4. Individuals with severe primary diseases of the heart, brain, lungs, kidneys, hematopoietic system, or endocrine system 5. Individuals with a history of abdominal surgery 6. Pregnant women, those with pregnancy intentions, or women who are breastfeeding 7. Individuals with mental or legal disabilities 8. Individuals who have participated in other drug clinical trials within the 3 months prior to this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Medicine Disease Efficacy: Using the Western medicine primary symptom grading and quantification standards, the four main symptoms are graded and scored, with each symptom corresponding to a score of 0-3. Assessments are conducted at the screening period, baseline, and on days 7, 14, 21, 28, and 56, with a focus on evaluating the efficacy based on the scores at day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Traditional Chinese Medicine (TCM) Syndrome Efficacy: Using the TCM syndrome grading and quantification standards, patients with syndromes such as Liver-Stomach Disharmony, Spleen-Stomach Dampness-Heat, and Food Retention are scored based on their symptoms. Assessments are conducted at the screening period, baseline, and on days 7, 14, 21, 28, and 56, with a focus on evaluating the efficacy based on the scores at day 28. 2. Gastric Emptying Time: The barium strip method is used to measure the gastric emptying rate at 3.5 hours. Observations and recordings are conducted once before medication (baseline) and once after 28 days of medication. 3. Changes in Tongue and Pulse Manifestations: A comprehensive inquiry and physical examination are conducted to observe changes in tongue and pulse before, during, and after treatment. Tongue manifestations are primarily assessed through visual inspection, observing the color of the tongue body and the condition of the tongue coating. Pulse manifestations are primarily assessed through palpation, where the patient's pulse is evaluated to determine its characteristics. | — |
Countries
China
Contacts
Public ContactTiancheng Qi
Outcome results
None listed