Thrombotic Superficial Phlebitis of the Lower Limbs
Conditions
Interventions
1:External application of Jinhuang Ointment combined with elastic bandage compression along with oral administration of a placebo for Phlebitis Granules.
2:External application of Jinhuang Ointment combined with elastic bandage compression along with oral administration of Phlebitis Granules.
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The diagnostic criteria for lower limb thrombotic superficial phlebitis are formulated with reference to Practical Peripheral Vascular Diseases and the 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis by the European Society for Vascular Surgery (ESVS). The condition is characterized by painful and tender nodules or cord-like structures accompanied by redness and warmth located in areas with pre-existing varicose veins particularly along the course of the great saphenous vein (GSV). Alternatively ultrasound examination may reveal the presence of thrombi within the vein thickening of the venous wall or inflammatory reactions. In the acute phase routine blood tests show an elevated white blood cell count.The Traditional Chinese Medicine (TCM) diagnostic criteria for the acute phase of blood-heat and blood stasis type ST are based on Integrated Diagnosis and Treatment of Peripheral Vascular Diseases in Traditional Chinese and Western Medicine and the TCM Syndrome Diagnosis and Efficacy Criteria. Symptoms include localized hard nodules or indurated cord-like structures skin pigmentation needle-like pain tenderness redness swelling and a burning sensation. In severe cases extensive red and swollen areas appear around the superficial veins. The tongue is dark red possibly with petechiae or ecchymosis and the coating is yellow and greasy. The pulse is deep thin and choppy.Inclusion Criteria:Meeting the above diagnostic and TCM criteria aged between 18 and 70 years with no gender restrictions. 18 70 Diagnosed with simple lower limb thrombotic superficial phlebitis or secondary to primary lower limb varicose veins.No prior treatment for the condition at the time of onset. A pain score of =40 mm on the Visual Analog Scale (VAS) at the time of consultation. Willing to participate in this study and providing signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Migratory thrombophlebitis; 2) Target blood vessels with active ulcers that have not healed or other severe conditions requiring surgical intervention; 3) Concomitant deep vein thrombosis; 4) Infectious skin and soft tissue diseases such as erysipelas acute lymphangitis and acute cellulitis; 5) Neutrophil count exceeding the upper limit of normal in routine blood tests; 6) Serum creatinine (Cr) exceeding the upper limit of normal or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) exceeding 1.5 times the upper limit of normal; 7) Severe primary diseases of major organs or systems including the heart liver kidneys and hematopoietic system; 8) Pregnant women women planning pregnancy within six months or breastfeeding women; 9) Patients with psychiatric disorders or cognitive impairment; 10) Individuals with known allergies to the investigational drug components or those with a history of allergic constitution; 11) Suspected or confirmed history of alcohol addiction or substance abuse; 12) Participation in other clinical trials within 30 days prior to screening; 13) Individuals deemed unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematorheology;Tumor Necrosis Factor-a;Pain VAS (Visual Analog Scale) score;Interleukin-6;Syndrome score;C-Reactive Protein; | — |
Countries
china
Contacts
Public Contactliuguob
Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed