Status:
UNKNOWN
BuqitongluO Granule for Qi Deficiency and Blood Stasis Syndrome
Lead Sponsor:
Dongzhimen Hospital, Beijing
Collaborating Sponsors:
The Affiliated Hospital of Changchun University of Chinese Medicine
The Affiliated Hospital of Shandong University of Chinese Medicine
Conditions:
Stroke, Ischemic
Coronary Artery Disease
Eligibility:
All Genders
35-80 years
Phase:
PHASE2
Brief 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 defici...
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 Def...
Eligibility Criteria
Inclusion
- Convalescence of ischemic stroke
- 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
- 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.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT04408261
Start Date
July 22 2020
End Date
December 1 2022
Last Update
April 1 2021
Active Locations (1)
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1
Dongzhimen Hospital
Beijing, Beijing Municipality, China, 100700