Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-17 @ 1:41 PM
Ignite Modification Date:
2025-12-22 @ 10:13 PM
NCT ID:
NCT04408261
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT04408261
Study Brief:
Protocol Section:
NCT04408261