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A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of Phlebitis Granules for the Treatment of Acute Thrombophlebitis (Blood Heat and Stasis Syndrome)

A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of Phlebitis Granules for the Treatment of Acute Thrombophlebitis (Blood Heat and Stasis Syndrome)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002483
Enrollment
Unknown
Registered
2025-12-24
Start date
2023-02-18
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Thrombophlebitis of superficial veins in acute phase

Interventions

High-dose group:Phlebitis Granules: Take 200-300 mL of boiling water for oral administration. Take 1 small box (containing 2 packets) at a time, three times a day.
Low-dose group:Phlebitis Granules and simulator, stirred with 200-300mL boiling water, once 1 small box (containing 1 packet of Phlebitis Granules + 1 packet of Phlebitis Granules simulator), three ti
Placebo group:Venous phlebitis granule simulator, take with 200-300 mL of boiling water, one small box (containing 2 bags) at a time, three times a day.

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for acute thrombophlebitis of superficial veins in Western medicine, classified as limb thrombophlebitis of superficial veins or thoracoabdominal wall thrombophlebitis of superficial veins; (2) Meets the diagnostic criteria for the syndrome of blood heat and stasis in traditional Chinese medicine; (3) Duration of illness at the time of consultation =5 days; (4) No prior treatment for the condition; (5) Pain VAS score at the time of consultation =40mm (integer value); (6) Age between 18-70 years, gender; (7) Informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Migratory thrombophlebitis of superficial veins; 2. Lesions with target vessels complicated by active ulcers that have not healed or other severe conditions requiring surgical intervention; 3. Patients with deep vein thrombosis; 4. Patients with skin and soft tissue infections, such as erysipelas, acute lymphangitis, or acute cellulitis; 5. Patients with neutrophil count exceeding the upper limit of normal in blood tests; 6. Patients with Cr exceeding the upper limit of normal or ALT or AST exceeding 1.5 times the upper limit of normal; 7. Patients with severe primary diseases of important organs or systems, such as heart, liver, kidney, or hematopoietic system; 8. Pregnant women, women planning pregnancy within six months, or breastfeeding women; 9. Patients with mental illness or cognitive impairment; 10. Patients with known allergies to components of the investigational drug or with a history of allergic constitution; 11. Patients with suspected or confirmed history of alcohol addiction or drug abuse; 12. Patients who have participated in other clinical trials within the past 30 days; 13. Patients deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
The time to disappearance of clinical symptoms and their disappearance rate.;Changes in pain VAS score compared to before medication.;

Secondary

MeasureTime frame
Traditional Chinese Medicine (TCM) Syndrome Efficacy;Efficacy;Time and rate of disappearance of single symptoms;The changes in blood inflammatory markers compared to baseline.;

Countries

China

Contacts

Public ContactLiu Guobin

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

15800885533@163.com15800885533

Outcome results

None listed

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