Effects of Liushen Pill on upper respiratory tract microecology, blood and intestinal metabolites in healthy people

Phase 1

Recruiting

• Conditions: A

• Registration Number: ITMCTR2000003292
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Aged >= 18 years old, male or female
(2) Male weight >= 50kg, female weight >= 45kg, body mass index (BMI) in the range of 19.0~26.0 kg/m2
(3) The subjects have no history of chronic diseases or serious diseases in cardiovascular, liver, kidney, respiratory, blood and lymph, endocrine, immune, mental, nervous, gastrointestinal and other systems;
(4) Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, blood transfusion, blood coagulation, pregnancy test (female), drug screening, etc.), abdominal ultrasound, 12-lead electrocardiogram results showed no abnormality or no clinical significance;
(5) The subject can communicate well with the researcher and understand and follow the requirements of this study.And agreed to sign the informed consent.

Exclusion Criteria

(1) Antibiotics were applied in the last 2 months;
(2) Patients with a history of gastrointestinal diseases (including existing gastrointestinal diseases) within 3 years, including patients with chronic or active upper gastrointestinal diseases such as dysphagia, esophageal diseases, gastritis, duodenitis, ulcer, gastrointestinal ulcer or active gastrointestinal bleeding or gastrointestinal surgery;
(3) Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, respiratory system, digestive system, urinary system, immune system, kidney, liver or metabolic disorders, or mental system diseases;
(4) Positive pregnancy test results of women with the possibility of pregnancy; Pregnant or lactating women, women of childbearing age who had unprotected sex with their partners within 14 days before the trial.
(5) Subjects with a history of smoking;
(6) Patients with severe diseases of the heart, brain, liver, kidney and hematopoietic system, malignant tumors, mental diseases and significant impairment of cognitive function;
(7) If the patient is physically allergic, he/she has a history of allergy to traditional Chinese medicine;
(8) Participants in other experiments within the last 3 months;
(9) According to the judgment of the researcher, there is a low possibility of enrollment or poor compliance.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pper respiratory tract flora;Biomarkers of intestinal metabolites;Blood metabolomics;