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

NCT07139639 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-08-24

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Lower Extremity Arterial Disease

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

Sponsors & Collaborators

  • Beijing Shijitan Hospital, Capital Medical University

    collaborator OTHER

  • Peking University Third Hospital

    collaborator OTHER

  • Dongzhimen Hospital, Beijing

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

    collaborator OTHER

  • Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Zheng Liu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-11-01
Completion
2028-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07139639 on ClinicalTrials.gov