Syndrome of Kidney-Yang Deficiency
Conditions
Interventions
8:Study Drug
Sponsors
Xi Yuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 50 years of age, the same group of subjects is not more than 10 years; 2. At least 45 kg for female subjects and 50 kg for male subjects, with a Body Mass Index (BMI) between 19-25kg/m2 (Including boundary value); 3. Physical examination showed no positive signs, such as heart, lung auscultation and normal blood pressure, chest, abdominal tapping, palpation, no abnormal findings, no obvious subcutaneous lymph node enlargement; 4. There was no clinical significance in the results of the results, such as routine examination of blood, urine and stool, blood biochemical examination, electrolyte examination, coagulation four indices and chest X-ray, abdominal ultrasound scan, ultrasound cardiogram and ECG. Note: imaging examination (chest X-ray, abdominal ultrasound scan, ultrasound cardiogram) can be accepted by the research center within 1 month; 5. Sign the informed consent form and voluntary to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. The result of laboratory examination, imaging examination, ECG and physical examination are clinically significant abnormal; 2. Alcohol and tobacco habit. There is alcohol abuse in the first year of screening who have alcohol abuse history (drinking 35g pure alcohol or 2 times drinking a day (1 time drinking = 150 mL liquor, or 360 ml beer, or 50 mL wine), or 1 cup of wine. And who is smoking within 3 months of screening (more than 10 cigarettes daily) and can not give up smoking and drinking during the study; 3. Drugs abusers (opioids drug or new-type drug had been used); 4. Participation in a drug research study within 3 months prior to receiving the study drug for this study; 5. Use of any drugs that damages a organ or being used within 3 months prior to receiving the study drug for this study; 6. Donation or loss of a significant volume of blood or plasma (> 400 mL) within 3 months prior to receiving the study drug for this study; 7. There is any clinical history of serious disease such as respiratory system, circulatory system, digestive system, genitourinary system, blood system, metabolism and endocrine system, motor system, nervous system, musculoskeletal system; 8. Have drug allergy history or allergic constitution, and can be allergic by the drug ingredients in this study; 9. Medical history of the heart, liver, kidney, digestive tract, breast, reproductive system (ovary, testicle, epididymis, uterus) and neuropsychiatric history; 10. The infection was screened positive; 11. Women in pregnancy and lactation; 12. Have birth plan within half a year or disagree to take effective measures to contraception during the study period; 13. Alcohol breath test positive (=5mg/100ml); 14. Use of any food that affects the activity of the liver enzyme in the first 14 days of the trial, or use a variety of drugs, health care products (including traditional Chinese medicine, homemade medicinal liquor, etc.); 15. Who have the symptoms of heat syndrome including fever, aversion to heat but prefer to cold, feel thirsty with desire to drink, flushed complexion, restlessness, yellow and thick phlegm or nasal discharge, deep-colored urinate, dry stool, red tongue with scant liquid, dry and yellow coating tongue, rapid pulse. These symptoms must diagnosised by two senior professional doctors who determine whether they meet the criteria of TCM heat syndrome; 16. The subjects not suitable to participate in this study judged by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactZhaoyun Zhu
Yunnan Baiyao Group Co., Ltd., Yunnan Institute of Materia Medica
Outcome results
None listed