BuqitongluO Granule for Qi Deficiency and Blood Stasis Syndrome

Coronary Artery Disease Clinical Trial

— BOSS  

Official title:

Buqitongluo Granule for Qi Deficiency and Blood Stasis Syndrome: A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408261
• Other study ID #: 2017L04609
• Status: Recruiting
• Phase: Phase 2
• Start date: July 22, 2020
• Est. completion date: December 2022

Study information

• Verified date: May 2020
• Source: Dongzhimen Hospital, Beijing
• Contact: Ying Gao, MD
• Phone: 0086-010-84013209
• Email: gaoying973[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Convalescence of ischemic stroke

Inclusion Criteria:

• Diagnosis of qi deficiency and blood stasis syndrome

• 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.

Exclusion Criteria:

• Confirmed secondary stroke caused by tumor, brain trauma, or hematological diseases by clinical examination;

• 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

Inclusion Criteria:

• 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 class?-?

• Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

• 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

Inclusion Criteria:

• 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:

• 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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Stable
• Angina, Stable
• Blind Loop Syndrome
• Coronary Artery Disease
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases
• Stroke, Ischemic

Intervention

Drug:
• 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.

Other:
• Standard care
Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing

Sponsors (18)

Lead Sponsor

Collaborator

Dongzhimen Hospital, Beijing

Beijing Chuanglikechuang Medical Technology Development Co., Ltd., Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, Jiangbin Hospital of Guangxi Zhuang Autonomous Region, Rizhao Hospital of Traditional Chinese Medicine, Shaanxi Buchang Pharmaceuticals Co., Ltd., Shanghai Youningwei Biotechnology Co., Ltd., The Affiliated Hospital of Changchun University of Chinese Medicine, The Affiliated Hospital of Chengdu University of Chinese Medicine, The Affiliated Hospital of Shandong University of Chinese Medicine, The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine, The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, The First Clinical Hospital of Jilin Academy of Traditional Chinese Medicine, The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Wuhan Third Hospital-Tongren Hospital of Wuhan University, Wuhan Zhizhi Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for convalescence of ischemic stroke	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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