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NOT YET RECRUITING
NCT07139639
EARLY_PHASE1

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

Sponsor: Zheng Liu

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2025-11-01

Completion Date

2028-12-01

Last Updated

2025-08-24

Healthy Volunteers

No

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