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A Clinical Study on the Intervention of Modified Qishen Liwei Formula in Elderly Primary Hypertension Combined with Frailty

A Clinical Study on the Addition and Subtraction Interventions of Qishen Liuwei Formula in Elderly Patients with Primary Hypertension Combined with Frailty (Qi Deficiency, Blood Stasis, and Phlegm-Dampness Syndrome)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000234
Enrollment
Unknown
Registered
2026-01-30
Start date
2024-09-23
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Hypertension in the elderly with frailty

Interventions

Experimental Group:Treatment with modified Qishen Liwei formula combined with conventional therapy. Composition of the herbal formula: Qishen Liwei formula (Radix Astragali 30g, Radix Salviae Miltiorr
Control Group:Conventional treatment

Sponsors

Beijing University of Chinese Medicine Oriental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for elderly hypertension and has had home-measured or inpatient blood pressure within the range of 90 mmHg =Systolic Blood Pressure= 150 mmHg and/or 60 mmHg =Diastolic Blood Pressure= 90 mmHg for three consecutive days prior to enrollment; (2) Meets the diagnostic criteria for frailty; (3) Patients diagnosed with qi deficiency and blood stasis, and/or spleen-kidney deficiency according to traditional Chinese medicine (TCM) differentiation; (4) No use of TCM herbal decoctions or finished TCM products in the past two weeks; (5) Voluntarily participates and signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with secondary hypertension; (2) Patients with concurrent diseases in the acute phase (e.g., acute coronary syndrome, acute cerebrovascular disease, active bleeding in hemorrhagic diseases, acute gout attack, infectious diseases, fractures, etc.); (3) Patients with unstable vital signs, bedridden status, or NYHA class IV heart failure; (4) Patients with any of the following conditions: severe arrhythmias (e.g., atrial fibrillation with rapid ventricular response, atrial flutter, paroxysmal ventricular tachycardia, etc.), pulmonary heart disease, rheumatic heart disease, myocarditis, cardiomyopathy, aortic dissection, pulmonary embolism, or other severe conditions; (5) Patients with serum alanine aminotransferase or serum creatinine levels exceeding twice the upper limit of the normal reference range.

Design outcomes

Primary

MeasureTime frame
Fried Frailty Scale;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Score;blood pressure control level;

Countries

China

Contacts

Public ContactZhou Kun

Beijing University of Chinese Medicine Oriental Hospital

dfzhk@126.com18810357440

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026