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Not yet recruiting NCT07139639

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

Early Phase I Interventional Diabetic Lower Extremity Arterial Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guanxinning Tablets, Matching Placebo for Guanxinning.
Who it may be relevant to
Registry conditions: Diabetic Lower Extremity Arterial Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Guanxinning Tablets
    Guanxinning Tablets * Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd. * NMPA Approval No. Z20150028 * Administration: 4 tablets orally, three times daily for 6 months
  • Drug 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

Primary outcome measures

  • Ulcer Recurrence Rate [Time frame: Measured at 6 months post-intervention]
Secondary outcome measures (5)
  • Ulcer Recurrence Rate [Time frame: Ulcer recurrence rates at 3, 9, and 12 months post-intervention]
  • Calculation of ulcer recurrence episodes [Time frame: Assessed at 6 months post-intervention]
  • Ankle-Brachial Index [Time frame: 6 and 12 months after intervention]
  • TCM Syndrome Score [Time frame: at 3 and 6 months post-intervention]
  • Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)、All-Cause Mortality [Time frame: 3, 6, 9, and 12 months after intervention]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • (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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗