deep vein thrombosis of lower limbs
Conditions
Interventions
experimental group:Mailuoshutong Pills + Mailuoning ranule Simulator,Mailuoshutong Pills: taken orally, 1 bottle at a time (12 pills/bottle), three times a day
Mailuoning granule simulant: taken as a drink, 1 bag each time (10g/ bag), three times a day.
Control group:Mailuoning granules + Mailuoshutong pill simulation Mailuoning granules: taken as a drink 1 bag each time (10g/ bag) three times a day
Mailuoshutong pill simulator: taken orally 1 bottle at a time (12 pills/bottle) three times a day
Sponsors
Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)For those who meet the Western medical diagnostic criteria for deep vein thrombosis of the lower limbs the clinical stage is the delayed stage (non-acute stage) which is 14 days to 3 months after the onset of disease; (2)Meets the syndrome differentiation standards of damp-heat and blood stasis syndrome in traditional Chinese medicine; (3)Aged between 18 and 70 years old (including the boundary value) gender is not limited; (4)Voluntarily sign the subject informed consent form.
Exclusion criteria
Exclusion criteria: (1) Acute DVT patients who plan to undergo thrombus removal procedures including catheter contact thrombolysis (CDT) percutaneous mechanical thrombectomy (PMT) or surgical thrombectomy; (2)Mental illness combined with serious cardiovascular cerebrovascular liver kidney hematopoietic system and other serious complications or combined with other serious primary diseases ALT or AST > 1.5 times the upper limit of normal value Cr > the upper limit of normal value; (3)Those who have had level 3 or 4 surgery within 14 days; (4)Those with a history of hemorrhagic stroke within 3 months; (5)Various coagulation disorders such as hemophilia idiopathic thrombocytopenic purpura and other bleeding diseases and those with active bleeding in the past 2 weeks; (6)People with allergies or allergies to any ingredients in this product and excipients; (7)Pregnant lactating women and women with pregnancy potential who refuse to maintain contraceptive measures approved by the researcher throughout the study process; (8)People who have participated in other clinical trials in the past month; (9)People suspected of having a history of alcohol or drug abuse; (10)Other circumstances that the researcher considers unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive disease efficacy (effective rate) after 4 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comprehensive disease efficacy (effective rate) after 2 weeks of treatment;The efficacy of quantitative symptom scores (skin temperature, skin color, pain, swelling of the affected limb, Homans sign, vein patency rate) after 2 weeks and 4 weeks of treatment;Efficacy of traditional Chinese medicine syndrome after 2 weeks and 4 weeks of treatment;Disappearance rate of individual traditional Chinese medicine symptoms after 2 weeks and 4 weeks of treatment;Changes in inflammation-related indicators (erythrocyte sedimentation rate, C-reactive protein) from baseline after 4 weeks of treatment;Changes in D-dimer from baseline after 4 weeks of treatment;Changes in traditional Chinese medicine Life Quality Evaluation Scale (CQ-D11) scores from baseline after 2 weeks and 4 weeks of treatment;Changes of NRS score of limb pain (swelling pain) NRS score of limb soreness and circumference of limb after 2 weeks and 4 weeks of treatment compared with baseline; | — |
Countries
China
Contacts
Public ContactYang Bohua
Dongzhimen Hospital Beijing University of Traditional Chinese Medicine
Outcome results
None listed