Evidence-Based Evaluation of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease

Официальное название

Evidence-Based Evaluation and New Drug Development of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease

Обзор

Taking the approach of promoting qi circulation and activating blood as the entry point, this study targets lower extremity arterial disease（LEAD） patients with TCM syndrome pattern of blood stasis due to qi stagnation. Using Guanxinning Tablets (a herbal formula with qi-moving and blood-activating properties) as the investigational medication, we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the classic herb pair (Chuanxiong Rhizoma-Salviae Miltiorrhizae) in preventing LEAD ulcer recurrence. This research aims to accumulate evidence-based medical data supporting new drug development.

Вмешательства

• Препарат Guanxinning Tablets
  Guanxinning Tablets * Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd. * NMPA Approval No. Z20150028 * Administration: 4 tablets orally, three times daily for 6 months
• Препарат Matching Placebo for Guanxinning
  Matching Placebo for Guanxinning Tablets * Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd. * Drug Product Certificate of Analysis Approval No.YF-R-C037A-2024104-A * Administration: 4 tablets orally, three times daily for 6 months

Первичные конечные точки

• Ulcer Recurrence Rate [Срок оценки: Measured at 6 months post-intervention]

Вторичные конечные точки (5)

• Ulcer Recurrence Rate [Срок оценки: Ulcer recurrence rates at 3, 9, and 12 months post-intervention]
• Calculation of ulcer recurrence episodes [Срок оценки: Assessed at 6 months post-intervention]
• Ankle-Brachial Index [Срок оценки: 6 and 12 months after intervention]
• TCM Syndrome Score [Срок оценки: at 3 and 6 months post-intervention]
• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)、All-Cause Mortality [Срок оценки: 3, 6, 9, and 12 months after intervention]

Критерии участия

Критерии включения

• Age: 18 to 80 years old (inclusive)
• Diagnosis: Confirmed type 1 or type 2 diabetes mellitus
• Meeting diagnostic criteria for diabetic lower extremity arterial disease (DLEAD)
• TCM Syndrome: Qualified for Qi Stagnation and Blood Stasis syndrome pattern
• Glycemic Control:

• HbA1c ≤9% or Fasting plasma glucose ≤10 mmol/L
• Ulcer History:

• Documented history of diabetic lower extremity arterial disease (DLEAD)-related ulcers, with confirmed healing (wound re-epithelialization without signs of redness, purulent discharge, or infection) 2-8 weeks prior to enrollment.
• Consent: Voluntarily signed informed consent form

Критерии исключения

• (1) Ulcer Etiology Exclusion:
• Pure pressure ulcers
• Pure neuropathic ulcers
• Immune-mediated ulcers (e.g., vasculitic ulcers caused by lupus, Behcet's disease, rheumatoid arthritis) (2) Recent Cardiovascular Events:
• Acute coronary syndrome within 3 months
• Hemorrhagic stroke within 3 months (3) Organ Dysfunction:
• Severe hepatic impairment (AST or ALT >1.5×ULN)
• Chronic kidney disease stage 4-5 (eGFR <30 mL/min/1.73m²) (4) Recent Major Bleeding:
• Gastrointestinal hemorrhage within 1 month (5) Concurrent TCM Therapy:
• Use of blood-activating/stasis-resolving TCM preparations for DLEAD within 1 week (6) Herbal Contraindication:
• Concurrent or planned use of \*Veratrum\*-containing preparations (7) Malignancy:
• Active cancer progression (8) Reproductive Status:
• Pregnant or lactating women (9) Allergy History:
• Known hypersensitivity to \*Ligusticum chuanxiong\* or \*Salvia miltiorrhiza\* (10) Cognitive/Language Barriers:
• Psychiatric disorders
• Intellectual/language impairment affecting scale completion
• Unwillingness to cooperate (11) Life Expectancy:
• <1 year (12) Clinical Trial Participation:
• Enrollment in other drug trials within 1 month (13) Investigator's Discretion:
• Other conditions deemed unsuitable for participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07139639 · 2025-035-03-KY · 2024ZD0532600, 2024ZD0532603

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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