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Clinical safety evaluation based on real-world TCM granules of key concern varieties

Clinical safety evaluation based on real-world TCM granules of key concern varieties

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025001730
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-05-07
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

adverse drug reaction

Interventions

Sponsors

First Affiliated Hospital of Guang zhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: (1) Patients whose doctor's prescription contains varieties of TCM granules of key concern or there are situations of unreasonable use of TCM granules;

Exclusion criteria

Exclusion criteria: (1) The patient was not taking TCM granules; (2) The patients had poor compliance and could not be followed up to the occurrence of adverse events; (3) The patient has participated in this study before; (4) Women of childbearing age who were pregnant nursing planning to become pregnant or unable to use effective contraception during the study period and men of childbearing age who were unable or unwilling to use effective contraception.

Design outcomes

Secondary

MeasureTime frame
The occurrence of serious adverse event;Occurrence of adverse drug reactions judged to be possibly relevant probably relevant and definitely relevant;Occurrence of serious adverse drug reactions judged to be possibly relevant probably relevant and definitely relevant;Occurrence of adverse events / adverse reactions of other formula granules used in combination with focused varieties Situation;

Primary

MeasureTime frame
The occurrence of adverse events;

Countries

China

Contacts

Public ContactZhongqi Yang

First Affiliated Hospital of Guangzhou Medical University

yang_zhongqi@163.com13688867618

Outcome results

None listed

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