Vascular Aging
Conditions
Interventions
Treatment group:Qixuekang Oral Liquid: Oral administration of 30 mL twice daily, administered before breakfast and dinner, for a treatment duration of 24 weeks
Placebo group:Placebo: Oral administration of 30 mL twice daily, administered before breakfast and dinner, for a treatment duration of 24 weeks
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 45–70 years, inclusive; both genders eligible; females must be postmenopausal. (2) Mean value of bilateral brachial-ankle pulse wave velocity (left and right baPWV) = 1400 cm/s. (3) Meeting the diagnostic criteria for Qi deficiency and blood stasis pattern in Traditional Chinese Medicine (TCM). (4) Voluntary participation in this study with signed informed consent.
Exclusion criteria
Exclusion criteria: 1: Participants will be excluded if they meet one or more of the following criteria: 1. Participation in any other clinical trial within 3 months prior to the start of this study. 2. Unstable or unsustainable lifestyle and underlying diseases, with probable changes in ongoing medication regimens or lifestyle habits (including smoking, tea consumption, diet, etc.) during the trial. 3. Premenopausal women 2: women with artificial menopause (e.g., after hysterectomy and adnexectomy) 3: women receiving hormone therapy. 4. Presence of any of the following diseases: 1) Severe cardiovascular and cerebrovascular diseases, including but not limited to: (1) Unstable angina pectoris or acute coronary syndrome 4: (2) Severe heart failure (NYHA functional class III–IV) 5: (3) Systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg. 2) Diabetes with unstable glycemic control and HbA1c = 6.5%. 3) Active, uncontrolled autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.) requiring immunosuppressants or biological agents. 4) Acute infection or active infection during the screening period. 5) Positive fecal occult blood test. 6) Severe musculoskeletal diseases (e.g., osteomyelitis, femoral head necrosis, myasthenia gravis, peripheral paralysis, etc.). 7) Severe hematological disorders. 8) Epilepsy, Parkinson's disease, psychiatric disorders, or cognitive impairment. 9) Peripheral vascular stenosis, malformation, or amputation. 5. Peripheral arterial disease (e.g., ABI = 0.9 at baseline screening). 6. Acute phase of severe chronic geriatric diseases or severe malignant diseases, such as acute exacerbation of chronic obstructive pulmonary disease, malignant tumor, or cachexia. 7. Use of any other Chinese medicinal herbs, proprietary Chinese medicines, or Chinese medicine granules with similar effects of tonifying qi and activating blood as Xueqikang within the past 1 month and during the trial. 8. Concomitant use or expected mandatory use of Wulingzhi, Lilu, Zaojia, or their preparations, which have antagonistic effects to Xueqikang. 9. Hypersensitivity to any known ingredients of the study medication (Notoginseng radix et rhizoma, Ginseng radix et rhizoma, Astragali radix, Puerariae lobatae radix) or excipients (honey, sucrose, sodium benzoate). 10. History of surgery within the past 4 weeks or clear surgical indications during screening, requiring surgical treatment in the near future as judged by the investigator. 11. Completely bedridden or physically disabled. 12. Pregnant or lactating women, or women planning pregnancy during the study. 13. History of alcoholism, drug addiction, or substance abuse. 14. Planned organ transplantation. 15. ALT and/or AST > 1.5 × upper limit of normal (ULN), or Scr > ULN. 16. Any other conditions deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brachial-ankle pulse wave velocity;Reactive Hyperemia Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| carotid intima-media thickness;Flow-mediated dilation of the brachial artery;Cardiopulmonary Exercise Testing;TCM Symptom Score,Quality of Life Score;1. Adverse Events and Serious Adverse Events;2. Vital Signs: body temperature, blood pressure, respiration rate, heart rate;3. Laboratory Tests: Hematology: complete blood count;Urinalysis: protein, glucose;Blood Biochemistry: liver function , renal function; glycated hemoglobin; Coagulation Function: prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen; 4. D-dimer 12-lead Electrocardiogram; | — |
Countries
China
Contacts
Public ContactChunhua Chi
Peking University First Hospital
Outcome results
None listed