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| Name | Class |
|---|---|
| Affiliated Hospital of Changchun University of Chinese Medicine | OTHER |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | OTHER |
| Chengdu University of Traditional Chinese Medicine |
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The main purpose of this trial is to evaluate the efficacy and safety of Buqitongluo Granule in treating qi deficiency and blood stasis syndrome, and explore the effect of the improvement of qi deficiency and blood stasis syndrome on the prognosis of diseases.
The BOSS study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Buqitongluo Granule will improve the syndrome score of Qi Deficiency and Blood Stasis in convalescence of ischemic stroke, stable angina pectoris of coronary artery disease and diabetic peripheral neuropathy with qi deficiency and blood stasis syndrome. Buqitongluo Granule will be compared to placebo, combined with guidelines-based standard care in patients. During the trial, it is forbidden to use acupuncture, Traditional Chinese Medicine decoction (compound granule), Traditional Chinese Medicine injection, Chinese patent medicine (including external use), external washing of Traditional Chinese Medicine and health product (composition or efficacy similar to the study drug).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buqitongluo Granule | Experimental | Subjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care. |
|
| Placebo | Placebo Comparator | Subjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buqitongluo Granule | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the syndrome score of Qi Deficiency and Blood Stasis | The dynamic evaluation will be defined by Evaluation Scale of Qi Deficiency and Blood Stasis Syndrome. The Evaluation Scale of Qi Deficiency and Blood Stasis Syndrome score ranges from 0 (best score) to 51 (worst score). | Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological impairment will be evaluated by National Institute of Health Stroke Scale (NIHSS) for convalescence of ischemic stroke | The NIHSS score ranges from 0 (best score) to 42 (worst score). | Baseline, at day 14, day 28, day 42 during treatment |
| Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for convalescence of ischemic stroke |
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Convalescence of ischemic stroke
Inclusion Criteria:
Exclusion Criteria:
Stable angina pectoris of coronary artery disease
Inclusion Criteria:
Exclusion Criteria:
Diabetic peripheral neuropathy
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Gao, MD | Contact | 0086-010-84013209 | gaoying973@126.com | |
| Weidi Liu | Contact | 0086-15301025939 | L305613099@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Gao, MD | Dongzhimen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital | Recruiting | Beijing | Beijing Municipality | 100700 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34733163 | Derived | 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. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | UNKNOWN |
| First Affiliated Hospital of Heilongjiang Chinese Medicine University | OTHER |
| Second Affiliated Hospital of Heilongjiang University of Chinese Medicine | OTHER |
| 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 |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Jiangbin Hospital of Guangxi Zhuang Autonomous Region | UNKNOWN |
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| Buqitongluo Granule Placebo | Drug | 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 | Other | Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy. |
|
Including limb numbness, swelling of hands or feet, spontaneous sweating (hemilateral sweating). Participants rated their symptoms on the 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm (no symptom) to 100 mm (worst symptom). |
| Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment |
| Continuous changes of Modified Rankin Scale for convalescence of ischemic stroke | The Modified Rankin Scale score ranges from 0 (best score) to 6 (worst score). | Baseline, at day 42 during treatment, and at 90 days after onset |
| Activities of daily living will be measured by Barthel Index (BI) score for convalescence of ischemic stroke | The Barthel Index score ranges from 0 (worst score) to 100 (best score). | Baseline, at day 42 during treatment, and at 90 days after onset |
| Quality of life will be measured by Short Form 36 (SF-36) Quality of Life Scale for convalescence of ischemic stroke | The SF-36 quality of life scale is used to monitor change in subject reported functionality, well-being, and overall health status. The score of each part ranges from 0 (worst score) to 100 (best score). | Baseline, at day 42 during treatment, and at 90 days after onset |
| Change of the Seattle Angina Questionnaire (SAQ) Score for stable angina pectoris of coronary artery disease | The maximum score is 100, and the higher the score, the better the quality of life and the state of body function of patient. | Baseline, at day 28 during treatment, at day 14 after treatment, and at 90 days after recruitment |
| Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for stable angina pectoris of coronary artery disease | Including chest tightness, chest pain, palpitation, fatigue, spontaneous sweating. Participants rated their symptoms on the 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm (no symptom) to 100 mm (worst symptom). | Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment |
| Change of the Clinical Scoring System of Toronto (TCSS) for diabetic peripheral neuropathy | TCSS includes a score of neural symptoms, nerve reflex scores and sensory examination. The TCSS score ranges from 0 (best score) to 19 (worst score). | Baseline, at day 14, day 28, day 42 during treatment, at day 14 after treatment, and at 90 days after recruitment |
| Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for diabetic peripheral neuropathy | Including local pain, limb numbness, paresthesia (e.g. burning sensation, formication, electrical sensation). Participants rated their symptoms on the 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm (no symptom) to 100 mm (worst symptom). | Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment |
| Quality of life will be measured by Short Form 36 (SF-36) Quality of Life Scale for stable angina pectoris of coronary artery disease and diabetic peripheral neuropathy | The SF-36 quality of life scale is used to monitor change in subject reported functionality, well-being, and overall health status. The score of each part ranges from 0 (worst score) to 100 (best score). | Baseline, at day 42 during treatment, and at 90 days after recruitment |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |