BuqitongluO Granule for Qi Deficiency and Blood Stasis Syndrome (BOSS)

Dongzhimen Hospital, Beijing

Status and phase: Unknown; Phase 2

Conditions: Coronary Artery Disease; Angina Pectoris, Stable; Stroke, Ischemic; Diabetic Peripheral Neuropathy

Treatments: Other: Standard care; Drug: Buqitongluo Granule; Drug: Buqitongluo Granule Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04408261

2017L04609

Details and patient eligibility

About

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.

Full 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).

Enrollment: 432 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 classⅠ-Ⅲ
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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432 participants in 2 patient groups, including a placebo group

Buqitongluo Granule

Experimental group

Description:

Subjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care.

Treatment:

Other: Standard care

Drug: Buqitongluo Granule

Placebo

Placebo Comparator group

Description:

Subjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care.

Treatment:

Other: Standard care

Drug: Buqitongluo Granule Placebo