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Short-term efficacy and safety of tolvaptan in the treatment of senile chronic venous insufficiency edema

Short-term efficacy and safety of tolvaptan in the treatment of senile chronic venous insufficiency edema

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064682
Enrollment
Unknown
Registered
2022-10-14
Start date
2022-10-14
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Chronic venous insufficiency

Interventions

The tolvaptan group:Take tolvaptan and adjust the dose
The placebo group:Take placebo

Sponsors

Guangzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. The subjects volunteered to cooperate with the study and signed an informed consent; 2. Patients admitted with chronic venous insufficiency; 3. Age: >=65 years old; 4. Patients with complete clinical data.

Exclusion criteria

Exclusion criteria: 1. Treatment with diuretic, dihydroergotamine, or intravenous active drugs in the past 6 weeks; 2. Patients with severe liver and renal impairment; 3. Patients with uncontrolled hypertension (systolic blood pressure >=180mmHg or diastolic blood pressure >=110mmHg); 4. Patients complicated with malignant tumors; 5. Cardiogenic or renal oedema; 6. Severe varicose veins require surgical treatment; 7. Having undergone varicose vein surgery; 8. Malicious ulcer; 9. Congenital vascular malformation; 10. Those who have participated in clinical trials of any other drugs or medical devices within 2 months before the screening.

Design outcomes

Primary

MeasureTime frame
Leg circumference / ankle circumference;Chronic venous insufficiency questionnaire;

Secondary

MeasureTime frame
Fasting weight;Urinary volume at 24 hours;6-min walking distance;Blood sodium;Urinary AQUA2 levels;Liver and kidney function;Lower limb vascular color ultrasound;

Countries

China

Contacts

Public ContactYang Chongzhe

Guangzhou First People's Hospital

aaron_10122000@126.com+86 13609785826

Outcome results

None listed

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