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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

Metabonomics Studies on the regulation of human physiological and biochemical functions by Huangqi oral solution

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2100005450
Enrollment
Unknown
Registered
2021-12-26
Start date
2021-12-26
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers

Interventions

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu province hospital of Chinese medicine)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
metabolome;

Contacts

Public ContactYin Jun-Gang
13451861518@139.com13451861518

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026