Diabetic Lower Extremity Arterial DiseaseEarly Phase 1NCT07139639
Evidence-Based Evaluation of Classic Herb Pair (Chuanxiong Rhizoma and Salviae Miltiorrhizae) for Preventing Recurrence of Diabetic Lower Extremity Arterial Disease
A Early Phase 1 study testing Guanxinning Tablets in people with Diabetic Lower Extremity Arterial Disease, run by Zheng Liu.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Lower Extremity Arterial Disease
- What is being tested?
- Guanxinning Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- (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:
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Guanxinning Tablets, Matching Placebo for Guanxinning
- Keywords
- Recurrence of ulcer, Diabetic Lower extremity arterial disease, Interventional Study, Prevention, Guanxinning Tablets, Salviae Miltiorrhizae, Chuanxiong Rhizoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guanxinning TabletsDrug
Guanxinning Tablets
- Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd.
- NMPA Approval No. Z20150028
- Administration: 4 tablets orally, three times daily for 6 months
Matching Placebo for GuanxinningDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Background Therapy Strict dietary control
Standardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines
Individualized antithrombotic regimen:
* First-line: Aspirin 100mg/d
* Alternative: Clopidogrel 75mg/d or other antithrombotic agents if aspirin allergy Note: Specific interventions adjusted based on actual clinical conditions Experimental Arm Background therapy + Guanxinning Tablets Receives: Drug: Guanxinning Tablets |
| Placebo Arm | Placebo comparator | ackground Therapy Strict dietary control
Standardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines
Individualized antithrombotic regimen:
* First-line: Aspirin 100mg/d
* Alternative: Clopidogrel 75mg/d or other antithrombotic agents if aspirin allergy Note: Specific interventions adjusted based on actual clinical conditions Placebo Arm Background therapy + Matching Placebo for Guanxinning Tablets Receives: Drug: Matching Placebo for Guanxinning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Recurrence Rate
Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100%
Measured: Measured at 6 months post-intervention
Secondary outcomes (5)
Ulcer Recurrence Rate
Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100%
Measured: Ulcer recurrence rates at 3, 9, and 12 months post-intervention
Calculation of ulcer recurrence episodes
Recurrence is counted based on the timing of occurrence. Ulcers appearing concurrently at distinct anatomical sites are counted as one episode; those occurring at different time points are counted as multiple episodes.
Measured: Assessed at 6 months post-intervention
Ankle-Brachial Index
Measured: 6 and 12 months after intervention
TCM Syndrome Score
TCM Syndrome Scoring Scale Description
This scale quantifies six core manifestations of Qi Stagnation and Blood Stasis Syndrome in diabetic lower extremity arterial disease, using a four-tier scoring system (0/2/4/6 points):
Limb coldness: Asymptomatic (0 pts); Occasional, self-relieved (2 pts); Persistent, relieved by warmth (4 pts); Persistent, unrelieved by warmth (6 pts)
Limb pain: None (0 pts); Mild (2 pts); Moderate (4 pts); Severe (sleep-disturbing) (6 pts)
Chest/abdominal distension: Absent (0 pts); Occasional mild (2 pts); Frequent moderate (4 pts); Frequent severe (6 pts)
Skin temperature: Normal (0 pts); Slightly decreased (2 pts); Significantly decreased (4 pts); Cold (6 pts)
Intermittent claudication: Absent (0 pts); Distance >500 meters (2 pts); 200-500 meters (4 pts); ≤200 meters (6 pts)
Foot coloration: Normal (0 pts); Dark red (2 pts); Pale/purplish-dark (4 pts); Cyanosis/ecchymosis (6 pts)
Measured: at 3 and 6 months post-intervention
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)、All-Cause Mortality
Measured: 3, 6, 9, and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Lower Extremity Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, Peking University Third Hospital, Dongzhimen Hospital, Beijing, Xuanwu Hospital, Beijing, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Sponsor-investigator, Zheng Liu, Affiliated Hospital of Shandong University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139639
- Sponsor's protocol ID
- 2025-035-03-KY
- Other IDs
- 2024ZD0532600, 2024ZD0532603
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07139639
- Acronym / sponsor ID
- 2025-035-03-KY
- Keywords
- Recurrence of ulcer, Diabetic Lower extremity arterial disease, Interventional Study, Prevention, Guanxinning Tablets, Salviae Miltiorrhizae, Chuanxiong Rhizoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Zheng LiuUniversity, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, Peking University Third Hospital, Dongzhimen Hospital, Beijing, Xuanwu Hospital, Beijing, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Guanxinning TabletsBackground Therapy Strict dietary control Standardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines Individualized antithrombotic regimen: * First-line: Aspirin 100mg/d * Alternative: Clopidogrel 75mg/d or other antithrombotic agents if aspirin allergy Note: Specific interventions adjusted based on actual clinical conditions Experimental Arm Background therapy + Guanxinning Tablets |
| Placebo Arm | Placebo comparator | Drug: Matching Placebo for Guanxinningackground Therapy Strict dietary control Standardized medication Administered according to glycemic, lipid, and blood pressure treatment guidelines Individualized antithrombotic regimen: * First-line: Aspirin 100mg/d * Alternative: Clopidogrel 75mg/d or other antithrombotic agents if aspirin allergy Note: Specific interventions adjusted based on actual clinical conditions Placebo Arm Background therapy + Matching Placebo for Guanxinning Tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (20 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guanxinning TabletsGuanxinning Tablets * Manufacturer: Zhengda Qingchunbao Pharmaceutical Co., Ltd. * NMPA Approval No. Z20150028 * Administration: 4 tablets orally, three times daily for 6 months | Drug | Experimental Arm |
| Matching Placebo for GuanxinningMatching 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 | Drug | Placebo Arm |
Primary outcome
Ulcer Recurrence Rate
Time frame: Measured at 6 months post-intervention
Ulcer Recurrence Rate = (Number of Subjects with Recurrent Ulcers / Total Subjects) × 100%
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Guanxinning Tablets in people with Diabetic Lower Extremity Arterial Disease, run by Zheng Liu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannan Wang (+86 13791130209, cweiyue@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer Recurrence Rate (time frame: Measured at 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.