chest tightness, asthma, cough, edema, limbs, cold, fatigue caused by Long-term congestive heart failure
Conditions
Interventions
trial group: Jiashen tablets
control group:placebo
Sponsors
The second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) healthy volunteers, men and women half, aged 18-35 years old, the same batch of subjects should not be younger than 10 years of age; (2) Male subjects weighing no less than 50Kg, female subjects weighing no less than 45Kg, all subjects with body mass index at 19-24 (including the critical value); (3) smuggling, alcohol and drug abuse test qualified, general physical examination and laboratory tests, chest radiograph, ECG and other physical and chemical tests are normal; (4) no history of major diseases, no smoking and alcoholism, women of childbearing age pregnancy test negative and not in lactation; (5) Under the GCP, obtain informed consent and volunteer.
Exclusion criteria
Exclusion criteria: (1) heart and kidney and other important organs have primary disease, history of gastrointestinal disease, metabolic disease history, history of neurological diseases; (2) QTcB extension (male> 450ms, female> 470ms); (3) have a history of drug allergy or allergies; (4) have hypokalemia and long QT family history of TdP risk factors such as family members; (5) patients with mental or physical disabilities; (6) physical examination, biochemistry, hematuria will be conventional and ECG, chest X-ray, ultrasound abnormalities, and clinical significance; (7) hepatitis B test, anti-HCV, HIV antibody test was positive; (8) within 3 months using known to have damage to an organism drugs, nearly 2 weeks had taken any drugs, 4 weeks participated in other clinical trials; (9) have bleeding tendency; (10) menstrual period, gestational age, lactating women and women of childbearing age taking contraceptives; (11) Abnormal vital signs (systolic blood pressure 140mmHg, diastolic blood pressure 90mmHg; heart rate 100bpm); (12) 3 months before the test more than 1 daily smoking or use a considerable amount of nicotine products, during the trial can not quit smoking, smoke test is positive; (13) Drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of alcohol), or alcohol test positive; (14) Drink plenty of tea, coffee and / or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day; (15) blood transfusion and blood donation history (blood volume greater than 200mL) in the last 3 months; (16) previous history of drug abuse, drug abuse test (morphine, methamphetamine, ketamine, dimethyl dioxy amphetamine, tetrahydrocannabinol, cocaine) positive; (17) According to the judge's judgment, not into the group (such as frail, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicators and clinical observation;QT/QTc interval; | — |
Countries
China
Contacts
Public ContactHuang Yuhong
The second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed