Spleen deficiency
Conditions
Interventions
Test group:Four Divine Spirits Jade Essence Paste, twice daily, 2 scoops (20g) per dose, taken continuously for 28 days.
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18–65 years (inclusive), no gender restrictions; (2) Diagnosed with spleen deficiency syndrome according to Traditional Chinese Medicine (TCM) pattern differentiation (meeting any of the following criteria qualifies for corresponding sub-pattern diagnosis: 2 primary and 2 secondary symptoms of spleen qi deficiency, spleen yin deficiency, or spleen yang deficiency plus tongue and pulse findings; or 1 primary symptom and 3 secondary symptoms plus tongue and pulse findings); (3) Hemoglobin (Hb) levels: males 80g/L = Hb 30 min), sleep maintenance disorder (=2 awakenings per night), early awakening, reduced sleep quality, and decreased total sleep time (typically <6.5 hours), accompanied by daytime dysfunction (primarily fatigue, depressed mood or irritability, physical discomfort, cognitive impairment, etc.); (5) Ability to complete the clinical study according to protocol requirements, with consent and signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals not meeting the diagnostic criteria for spleen deficiency syndrome or qi and blood deficiency syndrome; (2) Individuals with allergies to any component of the trial product; (3) Individuals who have used the following medications within the two weeks prior to the trial and cannot discontinue them (including iron-containing medications such as ferrous fumarate, ferrous citrate, etc.); Other chemical drugs with similar effects to the trial drug that directly impact evaluation metrics, such as vitamin B1, vitamin B2, etc.; Chinese patent medicines, such as Qi-Boosting and Blood-Nourishing Oral Liquid, Qi-Boosting and Blood-Nourishing Granules, etc.; Chinese herbs, such as Codonopsis, Ginseng, Pseudostellaria, Donkey-Hide Gelatin, Angelica, White Peony, Poria, etc.); (4) Individuals with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic system disorders, irritable bowel syndrome, inflammatory bowel disease, or gastrointestinal neoplastic lesions; (5) Women in preconception, pregnancy, or lactation periods; individuals with allergic constitutions; (6) Patients with mental disorders (e.g., depression, anxiety) or cognitive impairment; (7) Individuals with alcohol abuse, smoking (=10 cigarettes daily), or severely irregular schedules (e.g., staying up past 11 PM =5 days/week); (8) Individuals who have taken medications (e.g., qi-tonifying and blood-nourishing agents, hypnotics, gastrointestinal motility drugs) or health supplements affecting qi and blood, sleep, or spleen-stomach function within the past month; (9) Individuals who have participated in other clinical trials within the past 3 months; (10) Individuals deemed unsuitable for the clinical trial by the investigator or unable to complete the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative Grading Scoring Scale for Primary Symptoms of Spleen Deficiency Syndrome; Quantitative Grading Scoring Scale for Secondary Symptoms, Concomitant Symptoms and Physical Signs of Spleen Deficiency Syndrome; Quantitative Grading Scoring Scale for Tongue Manifestations of Subtypes of Spleen Deficiency Syndrome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Qi Deficiency and Blood Deficiency Syndrome Questionnaire in Traditional Chinese Medicine;Anemia-related indicators: Hemoglobin, Red blood cell count, Hematocrit, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Platelet count, Serum iron, Serum ferritin;Pittsburgh Sleep Quality Index;FS-14 Fatigue Scale;Fecal Consistency Score; | — |
Countries
China
Contacts
Public ContactYangyang
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed