Patients with Spleen-Stomach Qi Deficiency Syndrome
Conditions
Interventions
Observation Group:Observe patients receiving routine administration of Buzhong Yiqi Mixture without additional intervention on their original treatment and medication regimens.
Sponsors
Zhejiang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. TCM syndrome diagnosis criteria: (1) Patients with TCM syndrome differentiation matching Spleen-Stomach Weakness Syndrome, Qi Deficiency Fever Syndrome, Middle Qi Sinking Syndrome, or other relevant TCM patterns. Typical associated symptoms include poor appetite, lassitude and fatigue, disinclination to speak due to shortness of breath, pale tongue, feeble pulse, or anal prolapse, uterine prolapse, chronic diarrhea and dysentery, metrorrhagia; or fever with spontaneous sweating, preference for hot drinks, shortness of breath and fatigue, pale tongue, large and feeble pulse. 2. Western medical diagnosis criteria: (1) Digestive system diseases: Diarrhea-predominant irritable bowel syndrome, peptic ulcer, ulcerative colitis, chronic diarrhea, functional dyspepsia, etc. (2) Respiratory system diseases: Stable stage of chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, chronic cough, pediatric upper airway cough syndrome, etc. (3) Tumor-related disorders: Postoperative gastrointestinal function recovery, nausea and vomiting, poor appetite, cancer-related fatigue syndrome, etc. (4) Gynecological diseases: Uterine prolapse, habitual abortion, threatened abortion, postpartum urinary retention, female stress urinary incontinence, dysfunctional uterine bleeding, etc. 3. Meet the western medical diagnostic criteria for diseases of corresponding clinical departments, or the TCM diagnostic and syndrome differentiation criteria. 4. Aged 18–80 years old, with no restriction on gender. 5. Patients who are willing to receive treatment under this study protocol, have good treatment compliance, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who fail to meet the TCM syndrome differentiation criteria or western medical diagnostic criteria. 2. Subjects with known hypersensitivity to the investigational drug. 3. Pregnant or lactating women. 4. Patients suffering from severe cardiovascular, respiratory, renal, hematological, endocrine, neurological or psychiatric disorders, which, in the investigator's judgment, may: (1) Interfere with the accurate evaluation of the safety or efficacy of the investigational drug; OR (2) Expose the subject to unacceptable risks; OR (3) Impair the subject's ability to complete the scheduled study procedures. 5. Subjects with severe hepatic or renal dysfunction (ALT/AST > 3 times ULN, eGFR < 45 mL/min). 6. Patients who are unable to complete the required treatment course and observation period specified in the study for any reason. 7. Subjects with cognitive impairment who cannot cooperate to finish scale assessments. 8. Any other subjects deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Core Symptom Score of Functional Gastrointestinal Disorders (FGIDs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Anorectal Function Score;Quality of Life Score; | — |
Countries
China
Contacts
Public ContactChen Jun
Zhejiang Hospital
Outcome results
None listed