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Randomized double-blind placebo-controlled clinical trial of Guilingji capsule in delaying vascular aging

Randomized double-blind placebo-controlled clinical trial of Guilingji capsule in delaying vascular aging

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083654
Enrollment
Unknown
Registered
2024-04-29
Start date
2024-04-30
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Vascular aging

Interventions

Test group :Guilingji capsule: oral, once 0.6g (2 capsules), once, 2 hours before breakfast with light saline delivery, continuous oral administration for 24 weeks
Control group :Comfort capsule: oral, once 0.6g , once, 2 hours before breakfast with light salt water delivery, continuous oral administration for 24 weeks

Sponsors

Tongji Hospital Affiliated to Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 45-75 years (including boundary value, male and female); 2. Survival time = 6 months; 3. Brachial ankle pulse wave velocity (baPWV) = 1400cm / s; 4. In line with the TCM spleen and kidney deficiency diagnosis; 5. No comprehension, hearing or visual impairments, can perform general commands, communicate normally and complete physical assessment tests; 6. Patients who signed an informed consent form after informed consent and volunteered to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Acute or serious malignancy with serious chronic diseases of the elderly, such as acute exacerbations of COPD, acute coronary artery disease, Parkinson's disease, depression, pulmonary tuberculosis (other than old tuberculosis), malignancy and cachexia; 2. Antihypertensive drugs such as angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, and aldosterone antagonists, statins, and prostaglandins (such as oral preparations of beprostaglandin sodium) were taken within the last 1 month; 3. The heart function of the New York Heart Disease Association (NYHA) score was grade III to IV; 4. Previously diagnosed with diabetes mellitus; 5. Impaired liver and kidney function, in which ALT and / or AST > 2.0 times the upper limit of normal; Scr > 1.2 times the upper limit of normal value; 6. Patients with serious skeletal muscle disease (eg, osteomyelitis, osteonecrosis of the femoral head, myasthenia gravis, peripheral paralysis, etc.) 7. Those who have taken Traditional Chinese Medicine Patent Prescription, Chinese Medicine, Vitamin D, Vitamin K and hormone; 8. Those who are completely bedridden or have difficulty moving; 9. Allergy or allergy to known ingredients in this medicine; 10. Female subjects who are pregnant, lactating, or plan to become pregnant during participation in the trial; 11. Participants in other intervention trials.

Design outcomes

Primary

MeasureTime frame
BaPWV;

Secondary

MeasureTime frame
BaPWV;Carotid ultrasonic IMT thickness ;Vasodilatory function ;blood pressure ;Standard Scale of Fried Debilitating Syndrome ;Simple Intelligence Scale Score ;Ability of daily living scale score ;TCM Syndrome Scale Score ;Insomnia severity index;Pittsburgh Sleep Quality Index ;

Countries

China

Contacts

Public ContactCuntai Zhang

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

ctzhang0425@163.com+86 159 2766 8408

Outcome results

None listed

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