- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04408261
BuqitongluO Granule for Qi Deficiency and Blood Stasis Syndrome (BOSS)
March 29, 2021 updated by: Ying Gao, Dongzhimen Hospital, Beijing
Buqitongluo Granule for Qi Deficiency and Blood Stasis Syndrome: A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Interventional
Enrollment (Anticipated)
432
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Weidi Liu
- Phone Number: 0086-15301025939
- Email: L305613099@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100700
- Recruiting
- Dongzhimen Hospital
-
Contact:
- Weidi Liu
- Phone Number: 0086-15301025939
- Email: L305613099@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Buqitongluo Granule
Subjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care.
|
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.
Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.
|
PLACEBO_COMPARATOR: Placebo
Subjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care.
|
Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the syndrome score of Qi Deficiency and Blood Stasis
Time Frame: 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).
|
Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological impairment will be evaluated by National Institute of Health Stroke Scale (NIHSS) for convalescence of ischemic stroke
Time Frame: Baseline, at day 14, day 28, day 42 during treatment
|
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
Time Frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
|
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
Time Frame: Baseline, at day 42 during treatment, and at 90 days after onset
|
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
Time Frame: Baseline, at day 42 during treatment, and at 90 days after onset
|
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
Time Frame: Baseline, at day 42 during treatment, and at 90 days after onset
|
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
Time Frame: Baseline, at day 28 during treatment, at day 14 after treatment, and at 90 days after recruitment
|
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
Time Frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
|
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
Time Frame: Baseline, at day 14, day 28, day 42 during treatment, at day 14 after treatment, and at 90 days after recruitment
|
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
Time Frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
|
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
Time Frame: Baseline, at day 42 during treatment, and at 90 days after recruitment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 22, 2020
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
May 26, 2020
First Submitted That Met QC Criteria
May 26, 2020
First Posted (ACTUAL)
May 29, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 29, 2021
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Gastrointestinal Diseases
- Neuromuscular Diseases
- Intestinal Diseases
- Coronary Disease
- Malabsorption Syndromes
- Stroke
- Chest Pain
- Coronary Artery Disease
- Ischemic Stroke
- Peripheral Nervous System Diseases
- Angina Pectoris
- Angina, Stable
- Blind Loop Syndrome
Other Study ID Numbers
- 2017L04609
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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