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Study on the Mechanism of Efficacy of Qimiao Lianchuang Decoction in Treating Lower Extremity Venous Ulcers with Dampness-Heat Descending Syndrome

Clinical Study on the Efficacy Evaluation of Qimiao Lianchuang Decoction in Treating Lower Extremity Venous Ulcers with Dampness-Heat Descending Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002081
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-04-14
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Venous Leg Ulcer

Interventions

Control group:(1) Take Diosmin Tablets (Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd., National Drug Approval No. H20058471) 0.9g orally twice a day. (2) After routine disinfection of the wound,
anticoagulant, antiplatelet, vasodilator drugs are applied according to the patients condition
for severe infections, antibiotics are used based on the results of drug sensitivity tests.
Experimental group:In the treatment of the control group, Qimiao Lianzao Yin (12g of Phellodendron amurense, 9g of Atractylodes macrocephala, 30g of Coix Seed, 15g of Poria cocos, 12g of Atractylodes

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients meeting the diagnostic criteria for VLU and Liangchuang. (2) Patients diagnosed with the Dampness-Heat Descending Syndrome according to Traditional Chinese Medicine (TCM) pattern differentiation. (3) Patients classified as clinical grade C6 or C6r according to the CEAP classification. (4) Patients aged between 18 and 80 years (18 < age = 80). (5) Wound area = 25 cm² (for patients with multiple wounds, the larger wound will be selected). (6) Patients who have signed the informed consent form. (7) Patients with good compliance, capable of cooperating with treatment and observation.

Exclusion criteria

Exclusion criteria: (1) Patients with ulcers of other etiologies, such as arterial, vasculitic, or radiation-induced ulcers, are excluded. (2) Patients with severe comorbidities, including cardiac, cerebrovascular, hepatic, or renal insufficiency. (3) Patients with concurrent infectious diseases, malignancies, autoimmune diseases, hematological disorders, connective tissue diseases, severe psychiatric disorders, severe hypoproteinemia, or electrolyte imbalances. (4) Pregnant or lactating women. (5) Patients with severe lower limb lymphedema. (6) Patients with a history of allergy to the study medication.

Design outcomes

Primary

MeasureTime frame
Wound healing rate;

Secondary

MeasureTime frame
Tumor Protein p53 ;Mitogen-Activated Protein Kinase 3;

Countries

China

Contacts

Public ContactYannan Wang

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

hhl.003@163.com13791130209

Outcome results

None listed

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