Spleen Qi Deficiency Syndrome
Conditions
Interventions
Treatment group:Sijunzi Decoction Concentrate (Formulas I and II), once daily, taken in the morning and evening, diluted with warm water two hours after meals.
Control Group:Si Jun Zi Tang Decoction Compound Placebo, once daily, dissolve and take 2 hours after meals in the morning and evening.
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for spleen qi deficiency syndrome in traditional Chinese medicine (refer to the "Expert Consensus on the Diagnosis and Treatment of Spleen Deficiency Syndrome in Traditional Chinese Medicine (2023)"), with spleen qi deficiency syndrome as the primary syndrome, and may havesuch as spleen-kidney yang deficiency syndrome or spleen deficiency with dampness syndrome; (2) Age =18 years and =75 years, with no restriction on gender; (3) No use of spleen-qi tonifying Chinese herbal medicine or acupuncture, massage, and other traditional Chinese medical therapies targeting spleen deficiency syndrome within one month prior to enrollment; (4) Informed consent, voluntarily participates in the study, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals with severe issues in major organs (heart, lungs, liver, kidneys, brain) due to aging, including heart failure (orthopnea/leg edema) or severe arrhythmias (requiring a pacemaker); dialysis or serum creatinine > 3 mg/dL; ascites due to liver cirrhosis or hepatic encephalopathy; chronic obstructive pulmonary disease or chronic respiratory failure; dementia (unable to complete the questionnaire) or post-stroke sequelae (unable to live independently). (2) Individuals with diagnosed digestive system diseases (e.g., peptic ulcers, atrophic gastritis, ulcerative colitis) accompanied by corresponding disease symptoms, or those with severe impairment of liver and kidney function, malignant tumors, hematological diseases, or systemic diseases affecting the circulatory, respiratory, or nervous systems (e.g., moderate to severe PD/AD). (3) Individuals with severe mental disorders or cognitive impairments. (4) Individuals meeting diagnostic criteria for damp-heat syndrome of the liver and gallbladder, actual heat syndrome, or those with a constitution consistent with the above. (5) Patients with a history of alcohol abuse or substance misuse within the past year prior to screening. (6) Patients who have participated in other drug clinical trials within the past month prior to screening. (7) Patients with a known or suspected history of allergy to the investigational drug or its excipients, or with an allergic constitution. (8) Pregnant or breastfeeding female patients. (9) Patients with conditions that may violate the trial protocol or compromise their safety, as judged by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spleen Qi Deficiency Syndrome TCM Syndrome Scoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Symptom Scoring;Health-Related Quality of Life Assessment Using the SF-36 Health Survey Scoring;Chinese Quality of Life Scale Score;Depression Status Assessment Using the PHQ-9 Scale;Anxiety Assessment GAD-7 Scale Scoring;Body Composition Analysis; | — |
Countries
China
Contacts
Public ContactZhu Li
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed