Allergic rhinitis (syndrome of deficiency of kidney Yang and heat of lung)
Conditions
Interventions
Single dose group 1:Capsule
Specification: 0.4g/ granule
2 grain
For 1 day
Single dose group 2:Capsule
4 grain
Single dose group 3:Capsule
Single dose group 4:Capsule
Sponsors
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 ~ 50 years old, the age difference of the same group of subjects is no more than 10 years old, men and women are equal; 2. Body mass index (BMI= body mass index/height 2) ranges from 19 to 25 (including boundary value), with men weighing more than 50kg and women weighing more than 45kg; 3. No positive signs were found in physical examination, such as normal heart and lung auscultation and blood pressure, no abnormal findings in chest, abdomen tapping and palpation, no obvious swelling of subcutaneous lymph nodes; 4. Blood, urine and stool routine; Blood biochemical examination; Electrolyte testing; No clinically significant abnormality was found in the four items of coagulation, chest X-ray, abdominal b-ultrasound, echocardiography and electrocardiogram. Note: imaging examination (chest X-ray, abdominal b-ultrasonography, echocardiography) may be accepted within one month as a recognized examination report by the research center; 5. Informed consent, volunteer.
Exclusion criteria
Exclusion criteria: 1. Abnormal laboratory examination, imaging examination, electrocardiogram examination and physical examination with clinical significance; 2. A heavy smoker and alcoholic. 1 year prior to screening, there was alcoholism (with evidence of current alcoholism, that is, consumption of more than 35 grams of pure alcohol per day, i.e., two alcoholic drinks per day (1 alcoholic drink =150mL red wine, or 360mL beer or 50ml white wine), and those who could not abstain from alcohol during the trial period; Those who had smoked more than 10 cigarettes a day or the same amount of tobacco three months prior to screening and were unable to quit during the trial period; 3. Drug abusers (those who have used opiates or new drugs); 4. Those who have participated in other clinical trials within 3 months and have been selected into the group; 5. A person who has used a drug within three months that is known to damage a viscera or is currently taking the drug. 6. Over 400ml of blood was donated or lost within 3 months; 7. Any person with a history of serious clinical diseases, such as respiratory system, circulatory system, digestive system, urogenital system, blood system, metabolic and endocrine system, sports system, neuropsychiatric system, musculoskeletal system, etc.; 8. Those with a history of drug allergy or allergic constitution are allergic to the drug ingredients in this study; 9. History of heart, liver, kidney, digestive tract, breast, reproductive system (ovary, testis, epididymis, uterus) and neuropsychiatric system; 10. Infection screening is positive; 11. Pregnant and lactating women; 12. Those who had a family planning policy or who did not agree to take effective measures during the study period within the last six months; 13. Positive for alcohol exhalation test (greater than 5mg/100ml); 14. Any food, medicine and health products (including traditional Chinese medicine, self-made pharmaceutical liquor, etc.) that affect hepatic enzyme activity were used within 14 days prior to the test; 15. Symptoms include fever, bad heat, cold, thirst, thirst, red face, restlessness, thick sputum, yellow nose, short yellow urine, dry stool, red tongue, dry moss, less jin, pulse number and other clinical manifestations of heat syndrome. Two senior professional Chinese doctors also decide whether they meet the diagnostic criteria of TCM heat syndrome; 16. The researchers decided not to take part in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;ECG;24-hour dynamic electrocardiogram;blood routine;urine routines;stool routine;blood biochemical examination; | — |
Countries
China
Contacts
Public ContactRui gao
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Outcome results
None listed