NCT04408261Unknown2 期
Buqitongluo Granule for Qi Deficiency and Blood Stasis Syndrome: A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
Dongzhimen Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2020年7月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Change in the syndrome score of Qi Deficiency and Blood Stasis
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Buqitongluo Granule
Experimental
Subjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care.
干预措施: Buqitongluo Granule (Drug)
Buqitongluo Granule
Experimental
Subjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care.
干预措施: Standard care (Other)
Placebo
Placebo Comparator
Subjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care.
干预措施: Buqitongluo Granule Placebo (Drug)
Placebo
Placebo Comparator
Subjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care.
干预措施: Standard care (Other)
结局指标
主要结局
Change in the syndrome score of Qi Deficiency and Blood Stasis
时间窗: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
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).
次要结局
- Activities of daily living will be measured by Barthel Index (BI) score for convalescence of ischemic stroke(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(Baseline, at day 28 during treatment, at day 14 after treatment, and at 90 days after recruitment)
- Change of the Clinical Scoring System of Toronto (TCSS) for diabetic peripheral neuropathy(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(Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment)
- Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for convalescence of ischemic stroke(Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment)
- Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for stable angina pectoris of coronary artery disease(Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment)
- Neurological impairment will be evaluated by National Institute of Health Stroke Scale (NIHSS) for convalescence of ischemic stroke(Baseline, at day 14, day 28, day 42 during 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(Baseline, at day 42 during treatment, and at 90 days after recruitment)
- Continuous changes of Modified Rankin Scale for convalescence of ischemic stroke(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(Baseline, at day 42 during treatment, and at 90 days after onset)
研究者
Ying Gao
President of the Institute for Brain Disorders, Beijing University of Chinese Medicine
Dongzhimen Hospital, Beijing
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effectiveness and Safety of Yiqitongluo Granule for StrokeStrokeNCT02604654Yi Yang2,197
Unknown
2 期
A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome)Ischemic Heart FailureNCT02875639Zhu Mingjun180
招募中
2 期
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes PatientsType2diabetesDiabetesDiabetes Mellitus, Type 2NCT06575478Beijing Supreme Life Pharmaceutical Technology Co., Ltd.72
已完成
4 期
The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical StudyFunctional DyspepsiaNCT02460601Wuhan Union Hospital, China400
Unknown
2 期
A Clinical Evaluation of Baofeikang Granule in Combined Pulmonary Fibrosis and Emphysema TreatmentCombined Pulmonary Fibrosis and EmphysemaNCT02805699Beijing Municipal Science & Technology Commission120