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Randomized double-blind placebo parallel controlled trial for Buqi Jiedu Decoction in the treatment of qi deficiency and poisoning syndrome (carotid plaque ulcer, diabetic foot ulcer)

Randomized double-blind placebo parallel controlled trial for Buqi Jiedu Decoction in the treatment of qi deficiency and poisoning syndrome (carotid plaque ulcer, diabetic foot ulcer)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021343
Enrollment
Unknown
Registered
2019-02-16
Start date
2019-03-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid atherosclerotic plaque ulcer

Interventions

Control group:Placebo
Experimental group:Buqi Jiedu Decoction

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Carotid plaque ulcers are included in the criteria: (1) Color Doppler ultrasound confirmed carotid atherosclerotic plaque ulcer; (2) Those who are diagnosed with qi deficiency and poison damage syndrome; (3) Aged between 40 and 80 years old male and female; (4) lumen stenosis < 70%; (5) Those who can adhere to long-term medication; (6) Patients who volunteer to participate in the study, informed consent, and signed informed consent 2. Diabetic foot ulcers included in the standard: (1) Diagnosis of diabetic foot ulcers (grade 1-4); (2) Those who meet the diagnosis of qi deficiency and poison damage; (3) The course of lower extremity ulcer is more than 1 month; (4) The maximum ulcer area is 1-20 cm2; (5) Fasting blood glucose <= 10mmol / L; (6) Age between 40 and 80 years old, regardless of gender; (7) Those who can adhere to long-term medication; (8) Patients who volunteer to participate in the study, informed consent, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Carotid plaque ulcer exclusion criteria: (1) Patients with acute cardiovascular and cerebrovascular diseases; (2) History of previous cerebral hemorrhage; (3) Active ulcers and those with bleeding tendency, long-term use of anticoagulant drugs (such as warfarin); (4) Patients with severe arrhythmia, atrial fibrillation, and heart failure; (5) There are serious diseases such as heart, liver, kidney, hematopoietic system, endocrine system, respiratory system, etc., liver function is more than 1.5 times the upper limit of normal value; (6) Pregnant or lactating women; (7) Allergic constitution patients; (8) Statin intolerance; (9) Other diseases or mental illnesses that the investigator believes may limit efficacy evaluation or patient follow-up; (10) Patients who have participated in other drug clinical trials in the past 4 weeks. 2. Diabetic foot ulcer exclusion criteria: (1) Malignant diabetic ulcers; (2) Ulcers caused by other causes; (3) There are dead bones and infected bones at the end of the ulcer without surgical removal; (4) There are serious diseases such as heart, liver, kidney, hematopoietic system, endocrine system, respiratory system, etc., liver function is more than 1.5 times the upper limit of normal value; (5) Pregnant or lactating women; (6) Allergic constitution; (7) Other diseases or psychosis that the investigator believes may limit efficacy evaluation or patient follow-up; (8) Patients who have participated in other drug clinical trials in the past 4 weeks.

Design outcomes

Primary

MeasureTime frame
Changes of qi deficiency and poisoning syndrome before and after Chinese medicine intervention;Average onset time and average recovery time;

Countries

China

Contacts

Public ContactWu Shengxian

Dongzhimen Hospital, Beijing University of Chinese Medicine

wushx@sina.com+86 13501382919

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026