BuqitongluO Granule for Qi Deficiency and Blood Stasis Syndrome
NCT ID: NCT04408261
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
432 participants
INTERVENTIONAL
2020-07-22
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Buqitongluo Granule
Subjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care.
Buqitongluo Granule
Buqitongluo Granules were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
Standard care
Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.
Placebo
Subjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care.
Buqitongluo Granule Placebo
Buqitongluo Granule placeboes were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
Standard care
Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.
Interventions
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Buqitongluo Granule
Buqitongluo Granules were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
Buqitongluo Granule Placebo
Buqitongluo Granule placeboes were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
Standard care
Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ischemic stroke
* Age ≥ 35 and ≤ 80 years
* The interval from the onset to recruitment was 14-30 days
* NIHSS score ≥ 4 and ≤ 22
* Patient or legally authorized representative has signed informed consent.
* Diagnosis of qi deficiency and blood stasis syndrome
* Diagnosis of stable angina pectoris of coronary artery disease
* Age ≥ 35 and ≤ 80 years
* Canadian Cardiovascular Society (CCS) Classification of Angina Pectoris classⅠ-Ⅲ
* Patient or legally authorized representative has signed informed consent.
* Diagnosis of qi deficiency and blood stasis syndrome
* Diagnosis of diabetic peripheral neuropathies
* Age ≥ 35 and ≤ 80 years
* Patient or legally authorized representative has signed informed consent.
Exclusion Criteria
* Other conditions that lead to motor dysfunction (e.g. lameness, osteoarthrosis, rheumatoid arthritis, gouty arthritis), which render the neurological function examination unlikely to be assessed;
* Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or renal or hepatic insufficiency (hepatic insufficiency is defined as an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is 1.5 times the upper limit of normal, renal insufficiency is defined as a serum creatinine concentration value that is over the upper limit of normal);
* Other conditions or mental disorders which according to the judgement of researchers that restrict evaluation of mental function or render outcomes or follow-up unlikely to be assessed;
* Woman with pregnancy, lactation, or woman who wants to be pregnant in recent;
* Patient who is allergic to the study drug or has severe allergic constitution;
* Patient with yellow thick slimy tongue coating;
* Patient who has been participated in other drug or device clinical trials in recent 3 months.
Stable angina pectoris of coronary artery disease
* Acute coronary syndrome or unstable angina pectoris in the prior 3 months, or other heart diseases (e.g. cardiomyopathy, pericardial disease);
* Severe cardiopulmonary insufficiency (congestive heart failure NYHA class IV, severe abnormal pulmonary function), or severe arrhythmias (e.g. rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia);
* Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or renal or hepatic insufficiency (hepatic insufficiency is defined as an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is 1.5 times the upper limit of normal, renal insufficiency is defined as a serum creatinine concentration value that is over the upper limit of normal);
* Other conditions or mental disorders which according to the judgement of researchers that restrict evaluation of mental function or render outcomes or follow-up unlikely to be assessed;
* Woman with pregnancy, lactation, or woman who wants to be pregnant in recent;
* Patient who is allergic to the study drug or has severe allergic constitution;
* Patient with yellow thick slimy tongue coating;
* Patient who has been participated in other drug or device clinical trials in recent 3 months.
Diabetic peripheral neuropathy
* HbA1c \>10% in the screening period;
* Acute critical disease of diabetes mellitus in the prior 3 months (e.g. hyperglycemia and hypertonic syndrome, diabetic lactic acidosis, diabetic ketoacidosis);
* Severe heart disease, brain disease, or kidney disease;
* Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or renal or hepatic insufficiency (hepatic insufficiency is defined as an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is 1.5 times the upper limit of normal, renal insufficiency is defined as a serum creatinine concentration value that is over the upper limit of normal);
* Patient with spinal cord injury, cervical or lumbar vertebra disease (nerve root compression, spinal stenosis, cervical or lumbar vertebra degenerative disease), or sequelae of cerebrovascular disease, neuromuscular junction or muscular disease;
* Neuropathies caused by other diseases (e.g. Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), VitB deficiency, hypothyroidism, alcoholism, severe arteriovenous vasculopathy such as venous embolism, lymphangitis);
* Other conditions or mental disorders which according to the judgement of researchers that restrict evaluation of mental function or render outcomes or follow-up unlikely to be assessed;
* Woman with pregnancy, lactation, or woman who wants to be pregnant in recent;
* Patient who is allergic to the study drug or has severe allergic constitution;
* Patient with yellow thick slimy tongue coating;
* Patient with red tongue and scanty tongue coating;
* Patient who has been participated in other drug or device clinical trials in recent 3 months.
35 Years
80 Years
ALL
No
Sponsors
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The Affiliated Hospital of Changchun University of Chinese Medicine
UNKNOWN
The Affiliated Hospital of Shandong University of Chinese Medicine
UNKNOWN
The Affiliated Hospital of Chengdu University of Chinese Medicine
UNKNOWN
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
UNKNOWN
The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
UNKNOWN
The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
UNKNOWN
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
UNKNOWN
The First Clinical Hospital of Jilin Academy of Traditional Chinese Medicine
UNKNOWN
Shaanxi Buchang Pharmaceuticals Co., Ltd.
UNKNOWN
Beijing Chuanglikechuang Medical Technology Development Co., Ltd.
UNKNOWN
Shanghai Youningwei Biotechnology Co., Ltd.
UNKNOWN
Wuhan Zhizhi Medical Technology Co., Ltd.
UNKNOWN
Wuhan Third Hospital
OTHER
Rizhao Hospital of Traditional Chinese Medicine
UNKNOWN
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
UNKNOWN
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
UNKNOWN
Dongzhimen Hospital, Beijing
OTHER
Responsible Party
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Ying Gao
President of the Institute for Brain Disorders, Beijing University of Chinese Medicine
Principal Investigators
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Ying Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Dongzhimen Hospital
Locations
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Dongzhimen Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Liu W, Zhou L, Feng L, Zhang D, Zhang C, Gao Y; behalf of the BOSS Group. BuqiTongluo Granule for Ischemic Stroke, Stable Angina Pectoris, Diabetic Peripheral Neuropathy with Qi Deficiency and Blood Stasis Syndrome: Rationale and Novel Basket Design. Front Pharmacol. 2021 Oct 18;12:764669. doi: 10.3389/fphar.2021.764669. eCollection 2021.
Other Identifiers
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2017L04609
Identifier Type: -
Identifier Source: org_study_id
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