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Effectiveness and Safety of the Method of Fortifying the Spleen and Stomach and Draining Yin Fire for Treating Essential Hypertension: A Prospective, Non-interventional Real-World Study

Effectiveness and Safety of the Method of Fortifying the Spleen and Stomach and Draining Yin Fire for Treating Essential Hypertension: A Prospective, Non-interventional Real-World Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025002056
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Interventions

exposed group:Chinese herbal decoction primarily aimed at tonifying the spleen and stomach and draining Yin fire

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1: Meets the diagnostic criteria for either high-normal blood pressure or essential hypertension based on Western medicine standards; 2: Meets the diagnostic criteria for the syndrome of qi deficiency with yin fire flaming upward based on Traditional Chinese Medicine; 3: Age =18 years, of either sex; 4: Possesses adequate language expression and comprehension abilities; understands and voluntarily signs the informed consent form; cooperates with blood collection for laboratory tests; and is able to complete scale assessments.

Exclusion criteria

Exclusion criteria: 1: Secondary hypertension, including that caused by renal parenchymal disease and renal artery stenosis, pheochromocytoma, primary aldosteronism, or medications such as ephedrine; 2: Presence of severe non-cardiovascular diseases or conditions that affect life expectancy, such as a history of connective tissue disorders, malignant tumors, organ failure due to any cause, severe immune system disorders, or concurrent severe primary diseases of the liver, kidney, hematopoietic system, acute infectious diseases, or psychiatric disorders; 3: Concurrent other severe cardiovascular diseases, such as acute coronary syndrome or severe valvular heart disease; 4: Inability of the patient to cooperate with scale assessments and blood tests; 5: History of allergy to Chinese herbal medicine or other drugs; 6: The attending physician or investigator deems the patient unsuitable to participate in this study for other reasons; 7: Currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
blood pressure;

Secondary

MeasureTime frame
Blood Pressure Variability;Cardiovascular and cerebrovascular events;echocardiography;blood lipid;Chinese Medicine Symptom Score;Medication intake;Frailty index;

Countries

china

Contacts

Public ContactLi Xiao

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

lixiao617@hotmail.com13793188075

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026