exploring the effects of Huangqi Oral Solution on the metabolic profile and its related potential biomarkers or pathways in healthy volunteers using RP/HILIC-UPLC-TOFMS based metabolomics approach&#32

Phase 1

Recruiting

• Conditions: healthy volunteers

• Registration Number: ITMCTR2100005450
• Lead Sponsor: Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu province hospital of Chinese medicine)

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: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Healthy without history of heart, liver, kidney, digestive tract, nervous system, mental disorder and metabolic disorder.
2. Aged between 18 and 65, regardless of gender.
3. The weight (calculated by BMI = weight (kg) / height (M2)) is between 19.0 and 26.0.
4. Informed consent, voluntary test. The process of obtaining informed consent shall be in accordance with GCP.

Exclusion Criteria

1. The physical examination shows that the abnormalities of body temperature, blood pressure, heart rate, respiration, liver, spleen and kidney are of clinical significance; Physical and chemical examination showed abnormal blood routine (WBC, PLT), liver function (alt, AST) and renal function (BUN, Cr).
2. Those with positive symptoms or yin deficiency and Yang excess symptoms, such as irritability, restlessness, dry stool, dry mouth, bad breath, etc.
3. Take any other drugs within two weeks before the test.
4. Used drugs known to damage certain organs within three months.
5. Blood donors within three months.
6. Pregnant and lactating women.
7. Those who cannot give full informed consent due to intellectual or behavioral disorders.
8. Suspected or true history of alcohol and drug abuse.
9. According to the judgment of the researcher, other diseases that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in working environment, are easy to cause loss of follow-up.
10. Allergic constitution, such as a history of allergy to two or more drugs or food; Or known to be allergic to the ingredients of this drug.
11. Patients participating in clinical trials of other drugs.

Study & Design

• Study Type: Basic Science
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
metabolome;